Events

Recall of Device Recall CD45 APCH7

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

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
    56048
  • Event Risk Class
    Class 2
  • Event Number
    Z-0397-2011
  • Event Initiated Date
    2009-11-23
  • Event Date Posted
    2010-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92516
  • 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
    Analyte Specific Reagents - Product Code MVU
  • Reason
    Incorrect expiration date: product with an expiration date of 03/31/2010 was marked with an incorrect expiration date of 06/30/2010.
  • Action
    A Product Field Action Notification letter, dated November 2009, was sent to customers who purchased the affected device. The letter identified the affected device and explained the reason for recall. Customers were asked to not use the current CD45 APC H-7 lot number 58633 past 2010-03-31 until they receive their new lot of CD45 APC H-7 at no cost to them. Customers were also asked to complete and return the attached fax form. Questions should be directed to BD Customer Support Center at 1-877-232-8995.

Device

Device Recall CD45 APCH7
  • Model / Serial
    Model/Catalog number 641408, Lot/Serial # 58633
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CA, WA, NJ, UT, TX and OH.
  • Product Description
    BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. || CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).
  • Manufacturer
    BD Biosciences, Systems & Reagents

Manufacturer

BD Biosciences, Systems & Reagents
  • Manufacturer Address
    BD Biosciences, Systems & Reagents, 2350 Qume Dr, San Jose CA 95131-1812
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA