QIAstat-Dx Respiratory SARS-CoV-2 Panel — Class II medical device recall Z-0455-2022
Terminated recall by Qiagen Sciences LLC, reported 2022-01-12, distributed in AL, DC, KY, MD, ME, NJ, OK, PA…. The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes i
| Recall number | Z-0455-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2021-11-08 |
| Classified | 2022-01-05 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2023-03-29 |
| Distributed | AL, DC, KY, MD, ME, NJ, OK, PA, TX |
| Quantity | 376 kits |
| UPC / GTIN / UDI-DI | 14053228038846 |
| Lot numbers | 210209 |
| Serial numbers | 412092551, 412092552, 412092553, 412092554, 412092555, 412092556, 412092557, 412092558, 412092559, 412092560, 412092561, 412092563, 412092564, 412092565, 412092566, 412092567 |
| Model numbers | 691223 |
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Reason for recall
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
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-0455-2022. 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.