# FDA recall Z-0951-2022

> **Qiagen Sciences LLC** · Class II · device recall initiated 2022-02-25.

## Product

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.

## Distribution

AZ  CA  CT  FL  GA  IL  IN  MA  MN  NC  NY  OK  OR  PA  TN  TX  WV

## Key facts

- **Recall number:** Z-0951-2022
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-25
- **Report date:** 2022-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Germantown, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0951-2022

## Citation

> AI Analytics. FDA recall Z-0951-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0951-2022. Source: US FDA. Licensed CC0.

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