Reported Sep 21, 2016 · Terminated

VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of…

Biomerieux France Chemin De L'Or

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 France Chemin De L'Or · Chemin De L'Orme · Marcy L'Etoile, N/A · N/A

Is this the product you have?

  • VIDAS NT-pro-BNP Product UsageVIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure
Lot codes and dates
  • Reference number
    • 30449-01
    • Lot #1004474560
Amount recalled
229 kits

Where it was sold

Why it was recalled

Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 21, 2017 · Data as of Sep 19, 5:19 PM UTC

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