In Vitro Diagnostic GI Panel Recalled Due to Temperature Exposure During Shipping
BioFire Diagnostics is recalling FilmArray GI Panel diagnostic kits due to temperature excursions during shipping that may reduce test performance.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II precautionary recall of a diagnostic device due to temperature exposure during shipping. No actual failures, inaccurate results, or patient harm have been reported.
Plain-English summary
BioFire Diagnostics, LLC is recalling FilmArray GI Panel In Vitro Diagnostic (IVD) test kits.
The recall was initiated because the products experienced temperature excursions during shipping—storage conditions outside the manufacturer's required temperature specifications. Temperature exposure may reduce the performance of the diagnostic panel.
The affected kits have Part Number RFIT-ASY-0116, UDI 00815381020109, and Pouch Lot Number 1674322. Distribution was in the states of Florida and Georgia.
The recalled product
- Product
- In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 2
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)
- Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322
Distribution
Part of a larger recall action
This product is one of 3 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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