FDA-Device2021-08-25Class III
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Cell Marque Corporation
Hazard
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.
Sold states
Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.
Affected count
20
Manufactured in
6600 Sierra College Blvd, N/A, Rocklin, CA, United States
Products
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2311-2021Don't want to check this manually?
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