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Terminated

VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.

FDA Recall Z-2152-2014 · Posted 2014-08-06

Recalling FirmBioMerieux SA
Recall StatusTerminated
Product CodeMTF
Date Initiated2013-10-14
Date Terminated2017-08-28
Product Quantity1902

Reason for Recall

Product is not approved or authorized for distribution in the US.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

FL, LA, MI, MS, NV, OH, OK, TN, TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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