CLASS II Device recall · Reported 18 Mar 2020 · FDA Enforcement Report
FilmArray Gastronintestinal (GI) Panel recalled by BioFire Diagnostics
BioFire Diagnostics is recalling FilmArray Gastronintestinal (GI) Panel, distributed in Illinois, Kentucky, Mississippi, New Jersey. The recall was initiated on 8 Aug 2019 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-1451-2020
- FDA event ID
- 84825
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2019
- FDA classified
- 6 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 8 Aug 2019 | Recall initiated by company | |
| 6 Mar 2020 | Classified by FDA | +211 days |
| 18 Mar 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Where it was distributed
US: KY, IL, NJ, MS
Questions about this recall
Is FilmArray Gastronintestinal (GI) Panel recalled?
Yes. BioFire Diagnostics recalled FilmArray Gastronintestinal (GI) Panel on 8 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-1451-2020.
Why was it recalled?
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
Which lots are affected?
Kit Lot: 0537319 / Pouch Lot: 681619 Pouch Lot Date of Expiration 2020-05-30
Where was it sold?
US: KY, IL, NJ, MS
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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