Device product
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Z-1651-2022
Product summary
- Event
- Event 90691
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 kits
- Official record key
device-enforcement:Z-1651-2022
Official wording
Reason: 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
Code information: Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022
Distribution pattern: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
Derived failure modes
-
Unknown
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