CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
Biofire Filmarray Gastrointestinal recalled by BioFire Diagnostics
BioFire Diagnostics is recalling Biofire Filmarray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic, distributed in 16 states. The recall was initiated on 27 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0703-2024
- FDA event ID
- 93526
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Nov 2023
- FDA classified
- 10 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Nov 2023 | Recall initiated by company | |
| 10 Jan 2024 | Classified by FDA | +44 days |
| 17 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Where it was distributed
US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
CaliforniaConnecticutFloridaIowaIllinoisKansasMassachusettsMarylandMissouriNorth CarolinaNebraskaNew JerseyOhioTennesseeTexasUtah
Questions about this recall
Why was it recalled?
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
Which lots are affected?
UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6, 2024; 1746223/2XJA23/July 6, 2024
Where was it sold?
US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93526This product is part of a recall event; the main page for the event is The Biofire Respiratory Panel recalled by BioFire Diagnostics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Biofire Respiratory Panel recalled by BioFire Diagnostics | BioFire Diagnostics | Device Malfunction | 16 states |
More recalls from BioFire Diagnostics
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS II | Biofire Spotfire Respiratory/Sore Throat Panel recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled | Radiometer Medical ApS | Labeling Errors | Nationwide |
| Device | CLASS I | HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |
| Device | CLASS III | LeadCare II Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Other | Nationwide |
| Device | CLASS I | HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |