Recall Z-0951-2022— Qiagen Sciences LLC
Class II · Ongoing
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2022-02-25. FDA's recall record names no specific 510(k) clearance for this event. Product: therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD). Reason: False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit..
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-25
- Firm location
- Germantown, MD, United States
Product description
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Reason for recall
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.