Z-2152-2014Class II

VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific...

Name: Z-2152-2014 VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific...
Creator: BioMerieux SA
Published: 2013-10-14
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2013-10-14 / Terminated / root cause: packaging

FDA source

BioMerieux SA began a recall of VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma on 2013-10-14. FDA classified it as Class II and gives the reason as "Product is not approved or authorized for distribution in the US". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2152-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-14
Posted: 2014-08-06
Terminated: 2017-08-28
Recalling firm: bioMerieux, Inc.
Product: VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Product code: MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Reason for recall: Product is not approved or authorized for distribution in the US.
Root cause tag: packaging
FDA 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 in commerce: 1902
Distribution: FL, LA, MI, MS, NV, OH, OK, TN, TX
Product codes and lots: Lot 1001904130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2152-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2152-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-06

Product code MTF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)