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U.S. Department of Health and Human Services

Class 2 Device Recall CD45 APCH7

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  Class 2 Device Recall CD45 APCH7 see related information
Date Initiated by Firm November 23, 2009
Date Posted December 02, 2010
Recall Status1 Terminated 3 on December 03, 2010
Recall Number Z-0397-2011
Recall Event ID 56048
Product Classification Analyte Specific Reagents - Product Code MVU
Product 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).
Code Information Model/Catalog number 641408, Lot/Serial # 58633
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact
408-954-6307
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
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.
Quantity in Commerce 87 units
Distribution Nationwide Distribution -- CA, WA, NJ, UT, TX and OH.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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