Qiagen Sciences LLC Recall 90691
Description: FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Qiagen Sciences LLC Recall 90691 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1652-2022 |
| Event ID | 90691 |
| Event Description | FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 |
| Product Type | Devices |
| Distribution | IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand |
| Quantity | 9 kits |
| Recall 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 |
| Device Classification | 20220907 |
| Device Code Info | Lot number: 169047135 Exp Date: 12.06.2022 172017806 Exp. Date: 10.11.2022 |
| Center Classification Date | 20220829 |
| Recall Initiation Date | 20220720 |
| Recalling Firm | Qiagen Sciences LLC |
| Initial Notification | |
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