Z-1519-06

Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San...

Name: Z-1519-06 Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San...
Creator: Biogenex Laboratories
Published: 2006-09-05
License: https://open.fda.gov/license/

Biogenex Laboratories, Inc. / initiated 2006-09-05 / Terminated / root cause: labeling and UDI

FDA source

Biogenex Laboratories began a recall of Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA on 2006-09-05. The reason FDA records is "Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67". 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-1519-06
Status: Terminated
Initiated: 2006-09-05
Posted: 2006-09-23
Terminated: 2006-11-17
Recalling firm: Biogenex Laboratories, Inc.
Product: Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 9/5/06, the firm issued a notification letter to the consignees with a correct label to apply, and a return the reply form included with the letter.
Quantity in commerce: 13 vials.
Distribution: Worldwide distribution --- including state of Texas and countries of Amman, Jordan, and India.
Product codes and lots: Catalog Number AM371-5M, Lot number AM3710606, Expiration date June 2008.

Product code NJT

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)