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AccuDiag ™
Diagnostic Automation, Inc. · Model DACD1403-2 · UDI-DI 00850054026088
10
510(k) clearances
337
Adverse events
2
Recalls
13
Facilities
Description
AccuDiag ™Herpes Simplex 2 IgG (HSV 2 IgG) ELISA
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-13 | Diasorin Inc. | DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specif |
| 2021-02-08 | Siemens Healthcare Diagnostics, Inc | Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequen |
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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.