FilmArray GI diagnostic kits recalled due to false positive Norovirus results
BioFire Diagnostics is recalling FilmArray GI diagnostic test kits due to potential signals of increased false positive Norovirus results. Approximately 64,594 kits representing 2.3 million tests have been distributed worldwide.
What this means for you
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 is an FDA Class II diagnostic device recall due to potential signals of increased false positive test results. False positive diagnoses pose a risk of unnecessary medical interventions. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High severity score.
Plain-English summary
BioFire Diagnostics, LLC is recalling its FilmArray Gastrointestinal (GI) Panel diagnostic test kits due to potential signals of increased false positive Norovirus results. Two models are affected: RFIT-ASY-0116 (30-test kit) and RFIT-ASY-0104 (6-test kit). A total of approximately 64,594 kits representing 2,303,760 individual tests have been distributed.
The FDA classified this as a Class II recall. The hazard is the potential for false positive Norovirus test results, which could lead to incorrect diagnoses and unnecessary medical treatment decisions. No illnesses or injuries have been reported in association with this issue.
The affected diagnostic kits were distributed to healthcare facilities and laboratories throughout the United States, including all 50 states, Washington, D.C., and U.S. territories (Guam, Puerto Rico, and U.S. Virgin Islands). International distribution extended to over 60 countries across Europe, Asia, Africa, the Americas, and the Pacific region.
The recalled product
- Product
- FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
- Manufacturer
- BioFire Diagnostics, LLC
Distribution
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