FDA Medical Device Recalls (openFDA)
Qiagen Sciences LLC: therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
- Recall number
- Z-0951-2022
- Recalling firm
- Qiagen Sciences LLC
- Product
- therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
- Status
- Open, Classified
- Initiated
- 2022-02-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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 quality.communications@qiagen.com. 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: TechService-NA@qiagen.com
- Quantity
- 435 kits
- Distribution
- AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
- Lot, serial or model codes
- All lot numbers. GTIN number: 04053228002048
- 510(k) numbers
- not on file
- PMA numbers
- P110027
- Product code
- OWD
- Firm FEI
- 3003572099
- Firm city
- Germantown
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28