therascreen FGFR RGQ RT-PCR kit — Class II medical device recall Z-1650-2022
Ongoing recall by Qiagen Sciences LLC, reported 2022-09-07, distributed in IN, MN, NC, TX. Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequ
| Recall number | Z-1650-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2022-07-20 |
| Classified | 2022-08-29 |
| Reported by FDA | 2022-09-07 |
| Distributed | IN, MN, NC, TX |
| Countries outside the US | BE, CN, DE, ES, IT, JO, MY, NL, TH |
| Quantity | 22 kits |
| Lot numbers | 169046366, 172017274 |
| Model numbers | 874721 |
| Expiration dates | 2022-10-11, 2022-12-06 |
Product
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1650-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.