FILMARRAY GI Panel Software Recalled for False Positive Cryptosporidium Results
BioFire Diagnostics is recalling FILMARRAY Gastrointestinal Panel software due to an increased risk of false positive Cryptosporidium test results. Approximately 61,069 devices were distributed in the US and internationally.
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: FDA Class II diagnostic device recall with increased risk of false positive test results. No illnesses, injuries, or deaths reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3; absence of reported patient harm limits the maximum score to 3.
Plain-English summary
BioFire Diagnostics, LLC is recalling the FILMARRAY Gastrointestinal (GI) Panel Pouch Module Software (Part Numbers RFIT-ASY-0104 and RFIT-ASY-0116) due to an identified increased risk of obtaining false positive Cryptosporidium results.
The software issue creates a risk of incorrect test results that could lead to false diagnosis of Cryptosporidium infection. This may result in unnecessary treatment or further testing based on inaccurate diagnostic data.
Approximately 61,069 units with software versions prior to FLM2-SFW-0040 v2.0.3.1/BFS0001-5539 v2.0.200.10 were distributed across all US states, US territories, and internationally to healthcare facilities and clinical laboratories.
Healthcare providers should verify their FILMARRAY GI Panel devices are running the corrected software version and should review recent positive Cryptosporidium results for accuracy.
The recalled product
- Product
- FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 61,069
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 (1)
- Model/UDI-DI: RFIT-ASY-0104/00815381020116
Distribution
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