FilmArray 2.0 Diagnostic Instruments Recalled for Calibration Error Affecting Test Results
BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.
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 recall involves high-risk pathogens (Salmonella and MRSA) without reported illnesses or injuries. The calibration error causes diagnostic instruments to report false positive and false negative results, creating a risk of misdiagnosis through erroneous test results.
Plain-English summary
BioFire Diagnostics, LLC is recalling FilmArray 2.0 automated in vitro diagnostic instruments and modules. Some units manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may cause them to report higher melting temperatures than they should. This calibration error can lead to erroneous test results.
The calibration error may result in false positive results for Salmonella and Giardia lamblia, false positive and false negative results for Norovirus, and false negative results for MRSA. These diagnostic errors could lead to inappropriate clinical decisions and patient management.
The recalled instruments were distributed worldwide, including throughout the United States and to distributors in Canada, Mexico, Korea, Japan, China, Singapore, Chile, Australia, Greece, Hong Kong, and the Philippines. Facilities using affected FilmArray 2.0 instruments should contact BioFire Diagnostics for instructions on addressing this issue and determining whether their specific instruments are affected.
The recalled product
- Product
- FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 1,001
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 (20)
- FLM2-ASY-0001
- UDI: 00815381020031
- Serial Numbers: 2FA00610
- 2FA00951
- 2FA00964
- 2FA01005
- 2FA01115
- 2FA01116
- 2FA01128
- 2FA01418
- 2FA01653
- 2FA01733
- 2FA01771
- 2FA01775
- 2FA01878
- 2FA02805
- 2FA02977
- 2FA02981
- 2FA03194
- 2FA03196
Distribution
Part of a larger recall action
This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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