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artus® HSV-1/2 QS-RGQ MDx Kit

QIAGEN GmbH · Model 1 · UDI-DI 04053228004660

OQO Prescription
10
510(k) clearances
9
Adverse events
1
Recalls
7
Facilities

Recalls

DateFirmReason
2020-05-12DiaSorin Molecular LLCDue to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.