Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

biokitHSV-2 Rapid Test, REF: 300028001

HSV-2 rapid test may report false positive results.

Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720

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.

HSV-1 IgG ELISA kit ;

Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

HSV-2 IgG ELISA kit ;

Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

Biokit HSV-2 Rapid test Catalogue Number: 3000-28001.

Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.

Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395.

Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.

HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G

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 antigen band may lead to inaccurate interpretation of a sample as negative.