FDA Device recall Z-2152-2014
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or pla…
- FDA Device
- Class II
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class II recall of VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or pla… by Biomerieux, citing product is not approved or authorized for distribution in the US.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2152-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-14 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux |
| Distribution | FL, LA, MI, MS, NV, OH, OK, TN, TX |
Product
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Reason
Product is not approved or authorized for distribution in the US.
Identifiers
| code_info | Lot 1001904130 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2152-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.