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Lyra
QUIDEL CORPORATION · Model Direct HSV 1+2/VZV Assay · UDI-DI 30014613311027
PGI
Prescription
9
510(k) clearances
37
Adverse events
2
Recalls
11
Facilities
Description
Lyra Direct HSV 1+2/VZV Assay
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. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially |
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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.