Z-2779-2016Class III

VIDAS NT-pro-BNP

Name: Z-2779-2016 VIDAS NT-pro-BNP
Creator: Biomerieux France Chemin De L'Or
Published: 2016-04-15
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2016-04-15 / Terminated / root cause: packaging

FDA source

Biomerieux France Chemin De L'Or began a recall of 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... on 2016-04-15. FDA classified it as Class III and gives the reason as "Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2779-2016
Classification: Class III
Status: Terminated
Initiated: 2016-04-15
Posted: 2016-09-10
Terminated: 2017-07-21
Recalling firm: bioMerieux, Inc.
Product: 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.
Product code: NBC Test, Natriuretic Peptide
Reason for recall: Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
Root cause tag: packaging
FDA root cause: Packaging
Action: bioMerieux. sent an Urgent Product Removal Notice letter dated April 26, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check for affected products in their inventory and discard the incomplete products. Customers were asked to complete the attached Acknowledgement Form and return it via fax to bioMerieux. For questions contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666.
Quantity in commerce: 229 kits
Distribution: 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.
Product codes and lots: Reference number: 30449-01, Lot #1004474560.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2779-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2779-2016	Class III	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09

Product code NBC

K073091Class IIVidas Nt-Probnp Assay, Model: 30 449bioMerieux, Inc. / cleared 2008-02-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)