FDA Recall Open, Classified

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

Recall: Z-2311-2021 · Initiated July 15, 2021

Recall

Recall Number
Z-2311-2021
Event Number
88287
Firm
Cell Marque Corporation
FEI Number
3000718726
Product Code
NJT
Status
Open, Classified
Root Cause
Incorrect or no expiration date
Initiated
July 15, 2021
Address
6600 Sierra College Blvd, Rocklin, CA, 95677-4306

Description

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

Reason

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.

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 [email protected] or contact your local representative using the link: www.emdmillipore.com/offices

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.

Quantity

20