Z-1451-2020 Class II Terminated
FDA device recall Z-1451-2020 was initiated by BioFire Diagnostics, LLC on August 8, 2019 and is designated Class II. 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 whi… The recall status is terminated (terminated April 12, 2022). Affected quantity: 23 kits (690 pouches).
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2020
- Initiation Date
- August 8, 2019
- Termination Date
- April 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 kits (690 pouches)
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.
Distribution Pattern
US: KY, IL, NJ, MS
Code Information
Kit Lot: 0537319 / Pouch Lot: 681619 Pouch Lot Date of Expiration 2020-05-30