Events

Rappel de Device Recall EliA Sample Diluent, Article number, 83102301

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Phadia US Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    76343
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1253-2017
  • Date de mise en oeuvre de l'événement
    2017-01-30
  • Date de publication de l'événement
    2017-02-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152965
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Antibodies, anti-cyclic citrullinated peptide (ccp) - Product Code NHX
  • Cause
    Erroneous elia test results related to problems with liquid level detection and diluent pipetting in phadia 250 instruments, and deformed bottles. investigation showed problems with the liquid level detection in diluent bottle batch jjca resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
  • Action
    Phadia AB, part of Thermo Fisher Scientific, is voluntarily recalling EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C, written notices were mailed via FedEx on 01/30/2017. There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles for the below mentioned product and lots. The deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. The deformation is described as a flange or brim, located on the inside lower part of the vial opening. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: ¿ Stop using the affected lots of the above mentioned product lots ¿ Please, return or attest to scrapping of any unused product lots to the manufacturer and order replacement products free of charge. ¿ Review your records to determine if you have had instrument problems due to deformed bottles. If you find the instrument error message 3-145 RIGHT ARM LIQUID DETECTION BELOW LOWER LIMIT Target 2, please collect all log files available and/or contact customer support, who will further assist in assessing possible impact on the test results in scope. ¿ Fill in the Medical Device Recall return response on page 3 and return to the manufacturer by e-mail. If customers have any questions, please contact Phadia US, Inc. at 1-800-346- 4364, option #2.

Device

Device Recall EliA Sample Diluent, Article number, 83102301
  • Modèle / numéro de série
    EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None
  • Description du dispositif
    EliA Sample Diluent, Article number, 83-1023-01
  • Manufacturer
    Phadia US Inc

Manufacturer

Phadia US Inc
  • Adresse du fabricant
    Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
  • Société-mère du fabricant (2017)
    Fsii Sweden Holdings I Ab
  • Source
    USFDA