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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS Total Prostate Specific Antigen

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  Class 2 Device Recall VIDAS Total Prostate Specific Antigen see related information
Date Initiated by Firm October 14, 2013
Date Posted August 06, 2014
Recall Status1 Terminated 3 on August 28, 2017
Recall Number Z-2152-2014
Recall Event ID 68749
Product Classification in vitro diagnostic PSA - Product Code MTF
Product VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Code Information Lot 1001904130
Recalling Firm/
Manufacturer		 BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
For Additional Information Contact Alan Bergold, PhD
919-620-2000
Manufacturer Reason
for Recall		 Product is not approved or authorized for distribution in the US.
FDA Determined
Cause 2		 Packaging process control
Action A letter was issued on October 14, 2013 to consignees requesting the consignee to check their stock and destroy all kits of the VIDAS TPSA ref. 30428. The letter also requested that the consignee notify their accounts of the recall. An acknowledgment form was also included with the letter which is to be returned to BioMerieux.
Quantity in Commerce 1902
Distribution FL, LA, MI, MS, NV, OH, OK, TN, TX
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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