therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay… recallZ-2665-2023 · Qiagen GmbH · initiated Aug 22, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Qiagen GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid

FDA root cause category: Under Investigation by firm

What the company is doing

Qiagen US issued Urgent Medical Device Correction Letter to US consignees -therascreen KRAS RGQ PCR Kit (24), REF 870021 on 8/22/23 via email. Letter states reason for recall, health risk and action to take: This notice only applies to you if you downloaded and used the current version (Revision 13, January 2023) of the Instructions for Use. If you downloaded and used the current version (Revision 13, January 2023) of the Instructions for Use as mentioned above, follow these actions: o The dilution step of CRC tissue sample is incorrectly indicated and should not be followed. Follow the correct Action as described in this notice. o For NSCLC tissue sample follow the corrected Action as described in this notice. " Forward this information to all individuals and departments within your organization who are using the therascreen KRAS RGQ PCR Kit (24), REF. 870021. " If you are not the end user, please forward this notice to the product end user. " Review this notice with your laboratory/medical director. " Complete the Acknowledgement of Receipt Form attached to this letter by September 01, 2023, and email it to [email protected]. Actions taken by QIAGEN QIAGEN is working on updating the therascreen KRAS RGQ PCR Kit Instructions for Use . If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: [email protected]

Recall details

Recall number: Z-2665-2023
Status: Open, Classified
Initiated by the company: Aug 22, 2023
Posted by the FDA: Sep 29, 2023
Recalling firm: Qiagen GmbH
Product code: OWD
FDA submissions: P110027S012
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, KS, MA, NC,NY,OR, PA, TN, TX and the countries of KR, CN

Product description

therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)

Code information (models, lots, serial numbers)

GTIN number: 04053228002048 All lots that have an expiry date of March 2023 or later

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

therascreen® KRAS RGQ PCR Kit 1
QIAGEN GmbH · Somatic Gene Mutation Detection System
2 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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