Recall Z-2665-2023 ยท OWD Somatic Gene Mutation Detection System
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)
| Date | Sep 29, 2023 (initiated Aug 22, 2023) |
| Status | Open, Classified |
| 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 corre |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.