Z-2440-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 30, 2023
- Initiation Date
- May 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 Kits (30 pouches/kit)
Product Description
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Reason for Recall
Due to manufacturing issue, panels may result in false negative results.
Distribution Pattern
US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
Code Information
Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482