The Recall Desk
HighFDA (Devices)·Z-1392-2023·Announced 2023-04-26

BioFire FilmArray GI Panel Recalled for Potential False Negative Results

BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel test kits due to a manufacturing issue that may produce false negative results. Affected units may fail to detect gastrointestinal infections.

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 a Class II FDA medical device recall for a diagnostic test that may produce false negative results. No illnesses, injuries, or hospitalizations are reported, and the hazard is theoretical. Per the rubric, this qualifies as High severity under the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

BioFire Diagnostics, LLC is recalling 900 pouches (30 kits) of FilmArray Gastrointestinal (GI) Panel, model RFIT-ASY-0116, due to a manufacturing issue. The affected units are identified by Pouch Lot# 2N3R22 and Kit Lot# 2160422 (UDI-DI: (00)815381020109).

The manufacturing issue may cause the test panels to produce false negative results. This means that the test may fail to detect gastrointestinal infections when they are present.

The product was distributed nationwide to healthcare facilities and laboratories in Arkansas, California, the District of Columbia, Illinois, Kansas, Louisiana, Minnesota, North Carolina, New York, Oklahoma, and Wisconsin.

Patients who may have been tested using affected test kits should consult with their healthcare provider about the potential for a false negative result. Healthcare providers should immediately stop using product from affected lots and contact BioFire Diagnostics for information about obtaining replacement product.

The recalled product

Product
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Manufacturer
BioFire Diagnostics, LLC
Category
Medical Device — Diagnostics
Hazard
  • false-negatives

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 (2)

  • Pouch Lot# 2N3R22 / Kit Lot# 2160422
  • UDI-DI: (00)815381020109

Distribution

Distributed nationwide across the United States.

Related recalls

Same category