FDA Device recall Z-1651-2022
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
- FDA Device
- Class II
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 by Qiagen Sciences, citing 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 r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1651-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-20 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Qiagen Sciences |
| Distribution | IN, MN, NC, TX |
Product
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
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
Identifiers
| code_info | Lot number: 172017804 Exp Date: 10.11.2022 169046610 Exp. Date: 12.06.2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1651-2022%22
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