FDAMay 9, 2023device
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, In...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported
What to do
FDA enforcement status: Ongoing
Brands named
qiagen
UPCs
14053228038846
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a2025-03-12
- FDAQIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.12024-06-03
- FDAEZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 90032302024-03-04
- FDAtherascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)2023-08-22
- FDAQIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 6912142023-05-19
- FDAQIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 6912232023-05-19
- FDAQIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 6912232023-04-28
- FDAtherascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 8747112022-07-20
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