Reported Aug 13, 2014 · Terminated

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

BioMerieux SA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile, N/A · N/A

Is this the product you have?

  • VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Lot codes and dates
  • Lot 1001904130
Amount recalled
1902

Where it was sold

Why it was recalled

Product is not approved or authorized for distribution in the US.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 28, 2017 · Data as of Sep 19, 6:01 PM UTC

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