Z-1651-2022Class II

therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

Name: Z-1651-2022 therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Creator: Qiagen Sciences LLC
Published: 2022-07-20
License: https://open.fda.gov/license/

Qiagen / initiated 2022-07-20 / Open, Classified

FDA source

Qiagen Sciences LLC began a recall of therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 on 2022-07-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1651-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-20
Posted: 2022-08-29
Recalling firm: Qiagen
Product: therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Product code: OWD Somatic Gene Mutation Detection System
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
FDA root cause: Under Investigation by firm
Action: Qiagen issued July 20,2022 letter ( REF 874721) via email (A) US customers: notify customers by Urgent Medical Device Correction Letter; (B) CE customers: notify customers by Urgent Field Safety Notice (C) RUO (not IVD) customers: notify customers by Important Notice. Letter states reason for recall, health risk and action to take: For the continued use of REF 874721 therascreen FGFR RGQ RT-PCR Kit LOT 172017274 , please note the following criteria: Samples with the Overall sample result No Alteration Detected should be regarded as correct and no further actions are needed. Samples with the FGFR Alteration Detected results with Individual target result S249C Mutation Detected can be regarded as correct. This also includes samples with additional alterations detected. All other FGFR Alteration Detected results aside from S249C Mutation Detected should be disregarded and a retest for confirmatory positive result should be performed using the extracted RNA if available, or re-extracted if it is not. The following results should be assigned to the affected samples after the retest: l Retest result is positive for the same target(s)/ alteration(s): regard the result for the corresponding sample as positive. l Retest result is positive for different target(s)/ alteration(s) in the retest compared to the initial result: regard the result as indeterminate. l Retest is negative: the result for the corresponding sample should be regarded as negative l Retested sample is within an invalid run: repeat the run. l Result for individual sample is invalid in the retest: regard the result as indeterminate Forward this information to all individuals and departments within your organization who are using REF 874721 therascreen FGFR RGQ RT-PCR Kit. l If you are not the end user, please forward this notice to the product end user. l Review this notice with your laboratory/medical director. l Complete the Acknowledgement of Receipt Form attached to this letter by 28 July
Quantity in commerce: 29 kits
Distribution: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
Product codes and lots: Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1651-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1650-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-29
Z-1651-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-29
Z-1652-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-29

Product code OWD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)