therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Reported: April 27, 2022 Initiated: February 25, 2022 #Z-0951-2022
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.
Details
- Recalling Firm
- Qiagen Sciences LLC
- Units Affected
- 435 kits
- Distribution
- AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
- Location
- Germantown, MD
Frequently Asked Questions
What product was recalled? ▼
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD). Recalled by Qiagen Sciences LLC. Units affected: 435 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0951-2022.
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