FDA Medical Device Recalls (openFDA)
Cell Marque Corporation: Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
- Recall number
- Z-2311-2021
- Recalling firm
- Cell Marque Corporation
- Product
- Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
- Status
- Open, Classified
- Initiated
- 2021-07-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.
- Root cause
- Incorrect or no expiration date
- Action
- On 07/15/2021, recall notifications were mailed to consignees. Consignees were asked to do the following: Forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. In addition, if the affected product was further distributed, notify the associated customers of this issue and forward a copy of this recall notification. Examine your inventory to determine if you have any remaining Affected Product and quarantine from further use. Destroy any unused or partially used containers of the Affected Products rendering them unusable and provide us with confirmation that the Affected Products have been destroyed by returning the enclosed Confirmation of Receipt and Destruction form. For additional information please contact: Technical Services: Toll free at 800.665.7284 | Press 1 or email us at CellMarqueTS@milliporesigma.com or contact your local representative using the link: www.emdmillipore.com/offices
- Quantity
- 20
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.
- Lot, serial or model codes
- Item/Lot: 324M-15/0000116695, 324M-16/0000116696
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 3000718726
- Firm city
- Rocklin
- 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