FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Reported: March 18, 2020 Initiated: August 8, 2019 #Z-1451-2020
Product Description
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
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.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 23 kits (690 pouches)
- Distribution
- US: KY, IL, NJ, MS
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only. Recalled by BioFire Diagnostics, LLC. Units affected: 23 kits (690 pouches).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 18, 2020. Severity: Moderate. Recall number: Z-1451-2020.
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