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therascreen KRAS RGQ PCR Kit (24) recallZ-0951-2022 · Qiagen Sciences LLC · initiated Feb 25, 2022

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Qiagen Sciences LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

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.

FDA root cause category: Device Design

What the company is doing

Qiagen issued Urgent Medical Device Correction therascreen KRAS RGQ PCR Kit (24), REF 870021 letter on 2/25/22. Letter states reason for recall, health risk and action to take: This notice is only relevant for the analysis of samples originating from non-small cell lung cancer (NSCLC) tissue. For continued use of the therascreen KRAS RGQ PCR Kit (24), check the Flags/Warnings in the Sample Result table for automated interpretation of results. Sample results with one or more of the Flags/Warnings listed in this notice should be regarded as invalid with respect to the KRAS status and KRAS Mutation status. Setup a new PCR run to repeat the affected sample(s). To minimize Flags/Warnings for the controls and samples, strict compliance to the IFU guidance should be followed, including but not limited to: Correct reagent mixing is required, and must be ensured at each mixing step during the assay setup. Placement of the Rotor-Gene Q MDx according to Installation Procedures site requirements 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 March 10, 2022 and email it to [email protected]. QIAGEN is revising the Instructions for Use, as described in this notice, to reduce any risk resulting from the calling of a false positive or false negative G12C (12CYS) mutation result for NSCLC samples due to the Flags/Warnings listed in this notice and to emphasize strict compliance to the IFU guidance to minimize Flags/Warning. If you have any questions or concerns, pleas.se contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: [email protected]

Recall details

Recall number
Z-0951-2022
Status
Open, Classified
Initiated by the company
Feb 25, 2022
Recalling firm
Qiagen Sciences LLC
Quantity
435 kits
Product code
OWD
FDA submissions
P110027
Distribution
AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV

Product description

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

Code information (models, lots, serial numbers)

All lot numbers. GTIN number: 04053228002048

Devices named in this recall

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

Sources and updates

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