VIDAS TPSA — Class II medical device recall Z-2152-2014
Terminated recall by BioMerieux SA, reported 2014-08-13, distributed in FL, LA, MI, MS, NV, OH, OK, TN…. Product is not approved or authorized for distribution in the US.
| Recall number | Z-2152-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, N/A, France |
| Recall initiated | 2013-10-14 |
| Classified | 2014-08-06 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2017-08-28 |
| Distributed | FL, LA, MI, MS, NV, OH, OK, TN, TX |
| Quantity | 1,902 |
| Reason classes | unapproved product |
| Lot numbers | 1001904130 |
Product
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Reason for recall
Product is not approved or authorized for distribution in the US.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2152-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.