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Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
FDA product code PLO · Class 2 · Microbiology
5
Registered devices
23
Adverse events
2
Recalls
4
510(k) clearances
Devices with this code
QIAstat-Dx® Meningitis/Encephalitis (ME) Panel — QIAGEN GmbHSimplexa™ VZV Positive Control Pack — DIASORIN MOLECULAR LLCFilmArray® Meningitis/Encephalitis (ME) Panel — BIOFIRE DIAGNOSTICS, LLCSimplexa™ VZV Direct — DIASORIN MOLECULAR LLCFilmArray® Meningitis/Encephalitis (ME) Panel — BIOFIRE DIAGNOSTICS, LLC
Recent 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. |
| 2018-09-10 | BioFire Diagnostics, LLC | Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Onl |
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