Recall Z-0952-2022— 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) REF 874052 (Japan IVD, not released in the USA). 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) REF 874052 (Japan IVD, not released in the USA)
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.