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IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgG

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10381274 · UDI-DI 00630414964171

LGC

510(k) clearances

Adverse events

Recalls

Facilities

Description

HSV I and II IgG Ab - IMMULITE - RGT - 100 Tests

Recalls

Date	Firm	Reason
2022-09-28	Biokit, S.A.	HSV-2 rapid test may report false positive results.
2012-01-16	Diamedix Corporation	On 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.
2010-12-22	BioCheck Inc	Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
2010-12-22	BioCheck Inc	Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
2010-04-14	Biokit 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.
2010-04-14	Biokit 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.
2007-07-06	Focus Diagnostics Inc	A 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.