# FDA recall Z-1650-2022

> **Qiagen Sciences LLC** · Class II · device recall initiated 2022-07-20.

## Product

therascreen FGFR RGQ RT-PCR kit (US IVD)  REF 874721

## Reason for recall

Increased occurrence rate of false positive results,  lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects

## Distribution

IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand

## Key facts

- **Recall number:** Z-1650-2022
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-20
- **Report date:** 2022-09-07

- **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-1650-2022

## Citation

> AI Analytics. FDA recall Z-1650-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1650-2022. Source: US FDA. Licensed CC0.

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