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Aptima®
Hologic, Inc. · Model KIT, BOX 1, REFRIG, AHSV, 100T, IVD · UDI-DI 15420045507210
OQO
Prescription
1
510(k) clearances
9
Adverse events
1
Recalls
7
Facilities
Description
Aptima® HSV 1 & 2 Assay, 100 test, box 1 of 2 (2°C to 8°C box).
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. |
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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.