FDA Recall Terminated

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).

Recall: Z-0397-2011 · Initiated November 23, 2009

Recall

Recall Number
Z-0397-2011
Event Number
56048
Firm
BD Biosciences, Systems & Reagents
FEI Number
2916837
Product Code
MVU
Status
Terminated
Root Cause
Labeling mix-ups
Initiated
November 23, 2009
Posted
December 2, 2010
Terminated
December 3, 2010
Address
2350 Qume Dr, San Jose, CA, 95131-1812

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).

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.

Distribution

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

Quantity

87 units