Cell Marque Corporation Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Brand
Cell Marque Corporation
Lot Codes / Batch Numbers
Item/Lot: 324M-15/0000116695, 324M-16/0000116696
Products Sold
Item/Lot: 324M-15/0000116695, 324M-16/0000116696
Cell Marque Corporation is recalling Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 due to 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 ma. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026