BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes member

FDA device recall Z-0397-2011 · posted 2010-12-02 · Terminated

Recall details

Recalling firm

BD Biosciences, Systems & Reagents

Reason for recall

Incorrect expiration date: product with an expiration date of 03/31/2010 was marked with an incorrect expiration date of 06/30/2010.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

MVU

Quantity affected

87 units

Distribution

Nationwide Distribution -- CA, WA, NJ, UT, TX and OH.

Date initiated

2009-11-23

Date posted

2010-12-02

Date terminated

2010-12-03

Location

San Jose, CA