# FDA recall Z-0937-2021

> **Qiagen Sciences LLC** · Class II · device recall initiated 2020-12-11.

## Product

therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result.    REF 873121

## Reason for recall

Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.

## Distribution

CA, IN, MI, MN, NC, NJ, NM, OH, TX

## Key facts

- **Recall number:** Z-0937-2021
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-11
- **Report date:** 2021-02-03
- **Termination date:** 2022-04-22

- **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-0937-2021

## Citation

> AI Analytics. FDA recall Z-0937-2021. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-0937-2021. Source: US FDA. Licensed CC0.

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