Diagnostic Test Kits Recalled for False Vibrio Results With Certain Transport Medium
BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves false diagnostic results that could lead to unnecessary medical intervention. No reports of patient illness or injury exist in the source text. Per the rubric, scores are at most 3 when no illnesses/injuries are reported and the hazard is the diagnostic error itself.
Plain-English summary
The BIOFIRE FILMARRAY Gastrointestinal Panel is a diagnostic test kit designed to detect bacteria, viruses, and parasites in stool samples. Approximately 67,613 test kits have been recalled due to an issue affecting diagnostic accuracy.
The test kits produce false positive results for Vibrio and Vibrio Cholerae when used with certain lots of Remel Cary Blair transport medium. The affected transport medium lot numbers are 743930, 769240, 712258, 782425, 732357, and 742049.
The recall affects healthcare facilities and diagnostic laboratories using these products. Laboratories should verify whether they are using affected transport medium lot numbers. If so, they should discontinue use of the affected combination and contact BioFire Diagnostics for guidance on replacement products or alternative procedures.
The recalled product
- Product
- BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro…
- Manufacturer
- BioFire Diagnostics, LLC
Distribution
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