Biomerieux Recalls VIDAS NT-pro-BNP Kits Due to Packaging Error
Biomerieux is recalling 229 VIDAS NT-pro-BNP kits because they contain the incorrect number of control vials.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a packaging error regarding the number of control vials, which is a documentation/packaging issue unlikely to cause adverse health consequences.
Plain-English summary
Biomerieux is recalling 229 kits of the VIDAS NT-pro-BNP test. This automated quantitative test is used to determine the N-terminal fragment of B-type natriuretic peptide in human serum or plasma, serving as an aid in the diagnosis of suspected congestive heart failure.
The recall was initiated due to a packaging error. The affected kits do not contain the correct number of C1 or C2 control vials. The specific lot number is 1004474560, with reference number 30449-01.
The affected products were distributed nationwide in the United States, specifically in the states of Alabama, Arizona, California, Florida, Georgia, Iowa, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, South Carolina, Texas, Virginia, and West Virginia. Users should stop using the affected kits and contact Biomerieux for further instructions.
The recalled product
- 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…
- Manufacturer
- Biomerieux France Chemin De L'Or
- Hazard
- Affected units
- 229
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Reference number: 30449-01
- Lot #1004474560.
Distribution
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