Recall Z-2152-2014— BioMerieux SA
Class II · Terminated
Class II FDA medical device recall by BioMerieux SA, initiated 2013-10-14, terminated 2017-08-28. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- BioMerieux SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-14
- Terminated
- 2017-08-28
- Firm location
- Marcy L'Etoile, N/A, France
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.