FDA Medical Device Recalls (openFDA)
Qiagen GmbH: 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)
- Recall number
- Z-2665-2023
- Recalling firm
- Qiagen GmbH
- Product
- 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)
- Status
- Open, Classified
- Initiated
- 2023-08-22
- Posted
- 2023-09-29
- Terminated
- not on file
- Reason
- 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
- Root cause
- Under Investigation by firm
- Action
- 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 quality.communications@qiagen.com. 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: TechService-NA@qiagen.com
- Quantity
- not on file
- 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
- Lot, serial or model codes
- GTIN number: 04053228002048 All lots that have an expiry date of March 2023 or later
- 510(k) numbers
- not on file
- PMA numbers
- ["P110027S012"]
- Product code
- OWD
- Firm FEI
- 3004013603
- Firm city
- Hilden
- Firm state
- not on file
- Firm country
- Germany
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