---
title: "therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 — FDA record Z-1651-2022 | Is It on Recall"
description: "Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory."
url: https://isitonrecall.com/recall/fda-device-z-1651-2022-therascreen-fgfr-rgq-rt-pcr-kit-ce-ivd-not-sold-in-the-us-ref-874711/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 — FDA record Z-1651-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 20, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
- **Reason**: 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
- **Classification**: Class II
- **Recalling firm**: Qiagen Sciences LLC
- **Quantity**: 29 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1651-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1651-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Indiana](https://isitonrecall.com/state/indiana/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Sep 7, 2022
- **Recall initiation date**: Jul 20, 2022
- **Center classification date**: Aug 29, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1651-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Qiagen Sciences LLC records](https://isitonrecall.com/brand/qiagen-sciences-llc/)