Z-0397-2011

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

Name: Z-0397-2011 BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45...
Creator: BD Biosciences, Systems & Reagents
Published: 2009-11-23
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2009-11-23 / Terminated / root cause: labeling and UDI

FDA source

BD Biosciences, Systems & Reagents began a recall of 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... on 2009-11-23. The reason FDA records is "Incorrect expiration date: product with an expiration date of 03/31/2010 was marked with an incorrect expiration date of 06/30/2010". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0397-2011
Status: Terminated
Initiated: 2009-11-23
Posted: 2010-12-02
Terminated: 2010-12-03
Recalling firm: Becton, Dickinson and Company, BD Biosciences
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).
Product code: MVU Reagents, Specific, Analyte
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Model/Catalog number 641408, Lot/Serial # 58633

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)