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Pointe Scientific, Inc. HSV-1 & 2 IgG
HORIBA INSTRUMENTS INCORPORATED · Model T8007-96 · UDI-DI 00811727015211
LGC
Prescription
1
510(k) clearances
13
Adverse events
7
Recalls
18
Facilities
Description
Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-quantitative detection of human IgG antibodies to type 1 and type 2 herpes simplex virus (HSV) in human serum by enzyme immunoassay. To aid in the evaluation of the patient's immunological history with HSV, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 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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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.