FDAFDA · Food and drugs·Recall number Z-2152-2014
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Published August 13, 2014 · Recall initiated: October 14, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product is not approved or authorized for distribution in the US.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioMerieux SA
- Distributor
- FL, LA, MI, MS, NV, OH, OK, TN, TX
- Lot
- Lot 1001904130
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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