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illumigene HSV 1&2 External Control Kit
MERIDIAN BIOSCIENCE, INC. · Model 279960 · UDI-DI 00840733101151
PGI
Prescription
1
510(k) clearances
37
Adverse events
2
Recalls
11
Facilities
Description
The illumigene HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-05-12 | DiaSorin Molecular LLC | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially |
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