Device recall: therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

Class II FDA enforcement event 89914. Recall start date: 25 Feb 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Qiagen Sciences LLC started this device recall on 25 Feb 2022. The firm address in the FDA record is in Germantown, MD. FDA put the recall in Class II. FDA event 89914 has 2 product records. The first FDA enforcement report date is 27 Apr 2022. The record gives the status Ongoing.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Qiagen Sciences LLC, Germantown, MD.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 89914: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0951-2022	therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)	435 kits	Class II	Ongoing	27 Apr 2022
Z-0952-2022	therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)	8 Kits	Class II	Ongoing	27 Apr 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2022: 839
Share of these events in Class II: 88%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 18

Other events of the firm

Other FDA enforcement events of Qiagen Sciences LLC
Initiated	Product (first record)	Type	Class	Records
12 Mar 2025	Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version:	Device	Class II	1
3 Jun 2024	QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu	Device	Class II	1
4 Mar 2024	EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic an	Device	Class II	1
28 Apr 2023	QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223	Device	Class II	1
20 Jul 2022	therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721	Device	Class II	3
21 Nov 2021	QIAcube Connect MDx, Model No. 9003070	Device	Class II	1
8 Nov 2021	QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223	Device	Class II	1
15 Jan 2021	SARS-CoV-2 Antigen Test	Device	Class II	1
11 Dec 2020	therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be elig	Device	Class II	1
15 Jul 2020	QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative	Device	Class II	1

Qiagen Sciences LLC: all 18 events

Official channels

FDA enforcement report Z-0951-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 89914. https://recallregister.com/fda/ii/89914/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
What quantity of product is in FDA event 89914?: The event has 2 product records. The first record gives this quantity: 435 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 88% of the 839 device events that started in 2022 are in Class II.