Device Recall

Fabricant

  • Adresse du fabricant
    Boston Scientific Scimed, One Scimed Place, Maple Grove MN 55311-1566
  • Source
    USFDA

22687 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Product Code/Lot # LKPS1 424, Expiration Date 2013-08-31;  Product Code/Lot # LKPS1 425, Expiration Date 2013-10-31; Product Code/Lot # LKPS1 426, Expiration Date 2013-10-31;  Product Code/Lot # LKPS5 424, Expiration Date 2013-08-31;  Product Code/Lot # LKPS5 425, Expiration Date 2013-10-31; Product Code/Lot # LKPS5 426, Expiration Date 2013-10-31; Product Code/Lot # LKPTS1(D) D0104, Expiration Date 2013-08-31; Product Code/Lot # L2KPS2 379, Expiration Date 2013-07-31; Product Code/Lot # L2KPS2 380, Expiration Date 2013-08-31; Product Code/Lot # L2KPS2 381, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 382, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 383, Expiration Date 2013-10-31; Product Code/Lot # L2KPS2 384, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 379, Expiration Date 2013-07-31; Product Code/Lot # L2KPS6 380, Expiration Date 2013-08-31; Product Code/Lot # L2KPS6 381, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 382, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 383, Expiration Date 2013-10-31; Product Code/Lot # L2KPS6 384, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS2(D) D107, Expiration Date 2013-07-31; Product Code/Lot # L2KPTS2(D) D108, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS2(D) D109, Expiration Date 2013-10-31;  Product Code/Lot # L2KPTS6(D) D107, Expiration Date 2013-07-31; Product Code/Lot # L2KPTS6(D) D108, Expiration Date 2013-10-31; Product Code/Lot # L2KPTS6(D) D109, Expiration Date 2013-10-31.
  • Distribution
    Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: Albania, Afghanistan, Algeria, Argentina, Austria, Bangladesh, Belgium, Bolivia, Bosnia- Herzegovinia, Brazil, Bulgaria, Camaroon, Canada, Canary Islands, Chile, China, Colombia, Coast Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, South Africa, Rep. of Korea (S), Sweden, Switzerland, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, Uruguay, White Russia, Venezuela, and Vietnam.
  • Description du dispositif
    PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. || Product Usage: || For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers
  • Manufacturer
  • Modèle / numéro de série
    Affected Biological Indicator Lot No.: S-444
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
  • Description du dispositif
    Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ || EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
  • Manufacturer
  • Modèle / numéro de série
    Affected Biological Indicator Lot No.: S-444
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
  • Description du dispositif
    EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 || EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
  • Manufacturer
  • Modèle / numéro de série
    Affected Biological Indicator Lot No.:121101-447 and 121101-444
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
  • Description du dispositif
    Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 || The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
  • Manufacturer
  • Modèle / numéro de série
    Affected Biological Indicator Lot No.:121101-447 and 121101-444
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
  • Description du dispositif
    Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 || The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
  • Manufacturer
22682 en plus