Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
FDA device recall Z-1519-06 · posted 2006-09-23 · Terminated
Recall details
- Recalling firm
- Biogenex Laboratories
- Reason for recall
- Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.
- Action taken
- 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
- Status
- Terminated
- Product code
- NJT
- Quantity affected
- 13 vials.
- Distribution
- Worldwide distribution --- including state of Texas and countries of Amman, Jordan, and India.
- Date initiated
- 2006-09-05
- Date posted
- 2006-09-23
- Date terminated
- 2006-11-17
- Location
- San Ramon, CA
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