Events

Recall of Device Recall BD Bioscience BD CD56 PECy 7

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton, Dickinson and Company, BD Biosciences.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71826
  • Event Risk Class
    Class 2
  • Event Number
    Z-2453-2015
  • Event Initiated Date
    2015-07-17
  • Event Date Posted
    2015-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139167
  • Notes / Alerts
    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.
  • Extra notes in the data
    Reagents,specific,analyte - Product Code MVU
  • Reason
    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
  • Model / Serial
    Catalog number 335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution and Internationally to Taiwan.
  • Product Description
    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
  • Manufacturer Address
    Becton, Dickinson and Company, BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1812
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA