Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Reported: August 25, 2021 Initiated: July 15, 2021 #Z-2311-2021
Product Description
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
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.
Details
- Recalling Firm
- Cell Marque Corporation
- Units Affected
- 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.
- Location
- Rocklin, CA
Frequently Asked Questions
What product was recalled? ▼
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16. Recalled by Cell Marque Corporation. Units affected: 20.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Low. Recall number: Z-2311-2021.
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