Recall Z-1652-2022 ยท OWD Somatic Gene Mutation Detection System
Qiagen Sciences LLC
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
| Date | Jul 20, 2022 |
| Status | Open, Classified |
| Reason | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects |
| Root cause | Under Investigation by firm |
| Action | Qiagen issued July 20,2022 letter ( REF 874721) via email (A) US customers: notify customers by Urgent Medical Device Correction Letter; (B) CE customers: notify customers by Urgent Field Safety Notice (C) RUO (not IVD) customers: notify customers by Important Notice. Letter states reason for recall, health risk and action to take: For the continued use of REF 874721 therascreen FGFR RGQ RT-PCR Kit LOT 172017274 , please note the following criteria: Samples with the Overall sample result No Alteration Detected should be regarded as correct and no further actions are needed. Samples with t |
| Quantity | 9 kits |
| Distribution | IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.