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QIAstat-Dx® Meningitis/Encephalitis (ME) Panel
QIAGEN GmbH · Model V2 · UDI-DI 04053228043850
PLO
Prescription
4
510(k) clearances
23
Adverse events (9 deaths)
2
Recalls
5
Facilities
Description
IVD kit containing 6 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-05-12 | DiaSorin Molecular LLC | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
| 2018-09-10 | BioFire Diagnostics, LLC | Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.