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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm July 15, 2021
Create Date August 18, 2021
Recall Status1 Open3, Classified
Recall Number Z-2311-2021
Recall Event ID 88287
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Code Information Item/Lot: 324M-15/0000116695, 324M-16/0000116696
Recalling Firm/
Cell Marque Corporation
6600 Sierra College Blvd
Rocklin CA 95677-4306
Manufacturer 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.
FDA Determined
Cause 2
Incorrect or no expiration date
Action 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
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.