Z-1451-2020 Class II Terminated
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