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Terminated

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

FDA Recall Z-1519-06 · Posted 2006-09-23

Recalling FirmBiogenex Laboratories
Recall StatusTerminated
Product CodeNJT
Date Initiated2006-09-05
Date Terminated2006-11-17
Product Quantity13 vials.

Reason for Recall

Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide distribution --- including state of Texas and countries of Amman, Jordan, and India.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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