Home › Elitechgroup Mdx LLC › HSV 1&2 ELITe MGB Assay for CE-IVD
HSV 1&2 ELITe MGB Assay for CE-IVD
Elitechgroup Mdx LLC · Model RTK403ING · UDI-DI 03661540951947
10
510(k) clearances
2,745
Adverse events
30
Recalls
80
Facilities
Description
The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-20 | Abbott Molecular, Inc. | The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the foot |
| 2024-12-10 | Biocartis Nv | False-positive MSI-H results generated by the Idylla MSI Test. |
| 2024-03-20 | Abbott Molecular, Inc. | The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the me |
| 2024-02-01 | Abbott Molecular, Inc. | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. |
| 2023-12-15 | Hologic, Inc. | Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. |
| 2023-06-14 | DiaSorin Molecular LLC | There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc. |
| 2022-12-09 | Abbott Molecular, Inc. | The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have |
| 2022-11-11 | Abbott Molecular, Inc. | The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returne |
| 2022-10-12 | Abbott Molecular, Inc. | Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when th |
| 2022-06-22 | Meridian Bioscience Inc | When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.