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HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips

DIASORIN MOLECULAR LLC · Model IB0901 · UDI-DI 10816101021014

LGC Prescription
1
510(k) clearances
13
Adverse events
7
Recalls
18
Facilities

Recalls

DateFirmReason
2022-09-28Biokit, S.A.HSV-2 rapid test may report false positive results.
2012-01-16Diamedix CorporationOn 01/16/20112 Diamedix initiated a recall of IS-HSV 1&2 IgM Test Kit, Catalog # 720-350, Lot 60701, Exp. June 30, 2012. The Positive Control for this lot is Out of Specification.
2010-12-22BioCheck IncProduct labels indicate that the products are for IVD use and they do not have an approved 510(k).
2010-12-22BioCheck IncProduct labels indicate that the products are for IVD use and they do not have an approved 510(k).
2010-04-14Biokit U.S.A. Inc.Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.
2010-04-14Biokit U.S.A. Inc.Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.
2007-07-06Focus Diagnostics IncA small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common

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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.