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QMedix™
Diagnostic Automation, Inc. · Model DACD1444-2 · UDI-DI 00850054026644
10
510(k) clearances
13
Adverse events
7
Recalls
18
Facilities
Description
QMedix™ Herpes Simplex 1,2 IgM (HSV 1,2 IgM) ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use.
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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