Z-1651-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 7, 2022
- Initiation Date
- July 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 kits
Product Description
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Reason for Recall
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
Distribution Pattern
IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
Code Information
Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022