Recall Z-2152-2014 ยท MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
BioMerieux SA
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
| Date | Aug 6, 2014 (initiated Oct 14, 2013) |
| Status | Terminated |
| Reason | Product is not approved or authorized for distribution in the US. |
| Root cause | 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 | 1902 |
| Distribution | FL, LA, MI, MS, NV, OH, OK, TN, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.