The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of batch 1675622 of the discs for antibiotic sensitivity tests "Oxoid QD15 Quinupristin / Dalfopristin", reference CT1644B, manufactured by Thermo Fisher Scientific Microbiology Basingstoke, United Kingdom
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of use of batch 1675623 of the discs for antibiotic sensitivity tests "Oxoid Antimicrobial Susceptibility Testing Disc Penicillin G (P1)", reference CT0152B, manufactured by Thermo Fisher Scientific Microbiology Basinstoke, United Kingdom.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of lot 1686823 of the discs for antibiotic sensitivity tests "Oxoid Antimicrobial Susceptibility Testing Disc Gentamicin CN10", reference CT0024B, manufactured by Thermo Fisher Scientific Microbiology Basinstoke, United Kingdom
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of batches 1689092 and 1689093 of the discs for antibiotic sensitivity tests "Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin FOX30", reference CT0119B, manufactured by Thermo Fisher Scientific Microbiology Basingstoke, United Kingdom.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of batch 1647588 of the culture media Oxoid MacConkey Agar No. 3, reference CM0115B, manufactured by Thermo Fisher Scientific Microbiology Basingstoke, United Kingdom.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of batch 1580419 discs for antibiotic sensitivity tests "Oxoid Antimicrobial Susceptibility Testing Disc CN10 Gentamicin", reference CT0024B, manufactured by Thermo Fisher Scientific Microbiology Basingstoke, United Kingdom
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of batches 1545171 and 1545172 of the product "Oxoid Legionella BCYE Growth Supplement SR0110A", manufactured by Thermo Fisher Scientific Microbiology Basingstoke, United Kingdom.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of certain batches of polyvalent binding serum of Shigella dysenteriae (1-10), manufactured by Thermo Fisher Scientific Microbiology Basingstoke, United Kingdom, due to the possibility of obtaining false positive results.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of certain batches of the "Oxoid Listeria Latex" kit, manufactured by Thermo Fisher Scientific Microbiology Basingstoke, United Kingdom.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of lot 1174497 of discs for antibiotic sensitivity tests "Oxoid Antimicrobial Susceptibility Testing Disc VA30 (Vancomycin)", Ref .: CT0058B, manufactured by Thermo Fisher Scientific Microbiology Basingstoke, United Kingdom.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Lot 921911 of the Brucella Binding Serum, Ref .: ZM01 / R30164801, manufactured by Thermo Fisher Scientific Microbiology, United Kingdom, has been labeled with an incorrect title of 1/320, with the correct title being 1/1280.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Recall of lot 1154057 from Remel Streptex ™ Group D Latex Reagent, manufactured by Thermo Fisher Scientific Dartford, UK, due to the possibility of obtaining weak or false negative results.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain batches of the sample diluent for EliA and ImmunoCAP specific IgA / IgG sample diluent, manufactured by Phadia AB, Sweden, due to the presence of deformations in the bottles of the products.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Development of new lots of optimized Elia CCP wells, manufactured by Phadia AB, Sweden, so that when used with the new lots of Elia IgG conjugate, they do not produce increased measurements of anti-CCP signals.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility of increased measurements of anti-CCP signals when EliA ™ CCP Positive Controls are used in combination with certain batches of EliA ™ IgG conjugates (83-1017-01, 83-1005-01, 83-1002- 01, 83-1018-01), manufactured by Phadia AB, Sweden.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility that with batches 0018 and 0019 of the EliA SmDP Well reagent, manufactured by Phadia AB, Sweden, incorrect or ambiguous incorrect results are generated that are not related to anti-Sm antibodies.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Failure in quality control samples when using any lot of "ImmunoCAP Specific IgG / IgG4 i1 Control H", in combination with lots 389B7 and 389B8 of the allergen "ImmunoCAP Allergen i1", venom of apis melligera, 14-4143-01 , manufactured by Phadia AB, Sweden.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility of erroneous results with the Phadia 1000 analyzers, manufactured by Phadia AB, Sweden, when samples that have a bar code reading problem are handled in a certain way.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of certain batches of ImmunoCAP ISAC sIgE 112 manufactured by Phadia AB, Sweden, due to the possibility of obtaining false positive results with certain allergenic components.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Information regarding the clinical interpretation of the results of tests for the quantification of antibodies against soybean with the product ImmunoCAP Specific Ig E, manufactured by Phadia AB, Sweden.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain references and batches of the Lambda Cell Tray product, manufactured by One Lambda, Inc., USA, due to the fact that a high reaction background can be observed, which can cause negative reactions to appear positive.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Type II LABType® HD Classification Test DRB1, catalog number RSSOH2B1 / RSSOH2B1X, lot number 07B, expiration date 03/2014, manufactured by One Lambda, Inc, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Possibility of obtaining incorrect analytical results with specific Micro SSP Plates specific for DNA typing of HLA Class IB * 38/39 alleles, manufactured by One Lambda Inc., USA
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Cessation of use and review of the results obtained with certain batches of the lyophilized supplement Class I, reference CABC-1D, manufactured by One Lambda Inc., USA, due to the possibility that the product is not active.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notes supplémentaires dans les données
Action
Incorrect information about allele specificity for certain beads in user documents and catalog files of LABType DNA typing tests, manufactured by One Lambda Inc., USA