FDA Device recall Z-2779-2016
VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for…
- FDA Device
- Class III
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class III 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… by Biomerieux France Chemin De L Or, citing due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2779-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-04-15 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux France Chemin De L Or |
| Distribution | US |
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.
Reason
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
Identifiers
| code_info | Reference number: 30449-01, Lot #1004474560. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2779-2016%22
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