Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VIDAS TPSA Recalled by BioMerieux SA Due to Product is not approved or authorized for distribution...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BioMerieux SA directly.
Affected Products
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Quantity: 1902
Why Was This Recalled?
Product is not approved or authorized for distribution in the US.
Where Was This Sold?
This product was distributed to 9 states: FL, LA, MI, MS, NV, OH, OK, TN, TX
About BioMerieux SA
BioMerieux SA has 45 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report