VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in
FDA device recall Z-2152-2014 · posted 2014-08-06 · Terminated
Recall details
- Recalling firm
- BioMerieux SA
- Reason for recall
- Product is not approved or authorized for distribution in the US.
- Action taken
- 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
- Status
- Terminated
- Product code
- MTF
- Quantity affected
- 1902
- Distribution
- FL, LA, MI, MS, NV, OH, OK, TN, TX
- Date initiated
- 2013-10-14
- Date posted
- 2014-08-06
- Date terminated
- 2017-08-28
- Location
- Marcy L'Etoile, France
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