Biogenex Laboratories Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
Brand
Biogenex Laboratories
Lot Codes / Batch Numbers
Catalog Number AM371-5M, Lot number AM3710606, Expiration date June 2008.
Products Sold
Catalog Number AM371-5M, Lot number AM3710606, Expiration date June 2008.
Biogenex Laboratories is recalling Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGe due to Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TX
Page updated: Jan 10, 2026