Cell Marque Corporation: Medical Device Recall in 2021 - (Recall #: Z-2311-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: July 15, 2021

Date Posted: August 25, 2021

Recall Number: Z-2311-2021

Event ID: 88287

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.

Status: Ongoing

Product Quantity: 20

Code Information:

Item/Lot: 324M-15/0000116695, 324M-16/0000116696

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.

Voluntary or Mandated:

Voluntary: Firm initiated