CLASS III Device recall · Reported 21 Sep 2016 · FDA Enforcement Report
Vidas NT-pro-BNP recalled by Biomerieux France Chemin De
Biomerieux France Chemin De L'Or is recalling Vidas NT-pro-BNP, distributed nationwide in the US. The recall was initiated on 15 Apr 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2779-2016
- FDA event ID
- 73989
- Recalling firm
- Biomerieux France Chemin De L'Or, Marcy L'Etoile, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Apr 2016
- FDA classified
- 9 Sep 2016
- Reported
- 21 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Apr 2016 | Recall initiated by company | |
| 9 Sep 2016 | Classified by FDA | +147 days |
| 21 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
VIDAS NT-pro-BNP Product Usage: VIDAS¿ 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.
Where it was distributed
US Nationwide Distribution in the states of: AL, AZ, CA, FL, GA, IA, KS, KY, MA, MI, MN, NC, NE, NJ, NY, OH, SC, TX, VA and WV.
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIowaKansasKentuckyMassachusettsMichiganMinnesotaNorth CarolinaNebraskaNew JerseyNew YorkOhioSouth CarolinaTexasVirginiaWest Virginia
Questions about this recall
Why was it recalled?
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
Which lots are affected?
Reference number: 30449-01, Lot #1004474560.
Where was it sold?
US Nationwide Distribution in the states of: AL, AZ, CA, FL, GA, IA, KS, KY, MA, MI, MN, NC, NE, NJ, NY, OH, SC, TX, VA and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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