Events

Rappel de Device Recall BD Bioscience BD CD56 PECy 7

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 Becton, Dickinson and Company, BD Biosciences.

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
    71826
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2453-2015
  • Date de mise en oeuvre de l'événement
    2015-07-17
  • Date de publication de l'événement
    2015-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139167
  • 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
    Reagents,specific,analyte - Product Code MVU
  • Cause
    Three lots of cd56 pe cy 7, catalog number 335809, contain a low amount of hla-dr pe antibody which could result in an unexpected staining pattern.
  • Action
    BD Bioscience sent an Urgent Product Recall Letter dated July 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions : 1. If you have CD56 PE-Cy7 integrated into a Laboratory Developed Test (LDT) or panel, evaluate the impact of a false positive in the PE channel the interpretation of on the results. 2. Discard all remaining stock of CD56 PE-Cy7, Catalog Number 335809, lot number 4300708, 4304864, and/or 5013643, and request replacement product. BD will replace product at no cost. 3. As a requirement of our Regulatory Tracking Process, we request that you complete the enclosed Tracking/Verification form, even if you no longer have the affected reagents listed in your inventory. Please return the Tracking/ Verification form to BD Biosciences, per the instructions (mail, fax, or email). We apologize for any inconvenience that this may have caused and are working toward a long-term solution to this issue. If you require further assistance, please contact BD Customer Support at 877.232.8995 (prompt 3) in the United States. For customers outside the US, contact your local BD Biosciences representative or distributor.

Device

Device Recall BD Bioscience BD CD56 PECy 7
  • Modèle / numéro de série
    Catalog number 335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution and Internationally to Taiwan.
  • Description du dispositif
    BD CD56 PE Cy 7: NCAM16.2 ASR || Analyte Specific Reagent, Catalog number 335809 || Hematology: || The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
  • Manufacturer
    Becton, Dickinson and Company, BD Biosciences

Manufacturer

Becton, Dickinson and Company, BD Biosciences
  • Adresse du fabricant
    Becton, Dickinson and Company, BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1812
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA