Z-2311-2021Class III

Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

Name: Z-2311-2021 Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Creator: Cell Marque Corporation
Published: 2021-07-15
License: https://open.fda.gov/license/

Cell Marque Corp. / initiated 2021-07-15 / Open, Classified / root cause: labeling and UDI

FDA source

Cell Marque Corporation began a recall of Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 on 2021-07-15. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2311-2021
Classification: Class III
Status: Open, Classified
Initiated: 2021-07-15
Posted: 2021-08-18
Recalling firm: Cell Marque Corp.
Product: Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected] or contact your local representative using the link: www.emdmillipore.com/offices
Quantity in commerce: 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.
Product codes and lots: Item/Lot: 324M-15/0000116695, 324M-16/0000116696

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2311-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2311-2021	Class III	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-18

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)