FDA Medical Device Recalls (openFDA)
BioMerieux SA: VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
- Recall number
- Z-2152-2014
- Recalling firm
- BioMerieux SA
- Product
- VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
- Status
- Terminated
- Initiated
- 2013-10-14
- Posted
- 2014-08-06
- Terminated
- 2017-08-28
- 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
- Lot, serial or model codes
- Lot 1001904130
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MTF
- Firm FEI
- 1000611339
- Firm city
- Marcy L'Etoile
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28