The Recall Desk
ModerateFDA (Devices)·Z-1253-2023·Announced 2023-03-22

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.

What this means for you

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
Category
Medical Device — In Vitro Diagnostic
Hazard
  • temperature-excursion
  • reduced-performance

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

Distributed nationwide across the United States.

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