FDA Medical Device Recalls (openFDA)
Biogenex Laboratories: Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
- Recall number
- Z-1519-06
- Recalling firm
- Biogenex Laboratories
- Product
- Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
- Status
- Terminated
- Initiated
- 2006-09-05
- Posted
- 2006-09-23
- Terminated
- 2006-11-17
- Reason
- Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.
- 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
- 13 vials.
- Distribution
- Worldwide distribution --- including state of Texas and countries of Amman, Jordan, and India.
- Lot, serial or model codes
- Catalog Number AM371-5M, Lot number AM3710606, Expiration date June 2008.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 2936532
- Firm city
- San Ramon
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28