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Cell Marque Corporation Recall 88287

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

Cell Marque Corporation Recall 88287 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2311-2021
Event ID88287
Event DescriptionCell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.
Recall ReasonMouse 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.
Device Classification20210825
Device Code InfoItem/Lot: 324M-15/0000116695, 324M-16/0000116696
Center Classification Date20210818
Recall Initiation Date20210715
Recalling FirmCell Marque Corporation
Initial Notification Letter
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