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Alinity m
ABBOTT MOLECULAR INC. · Model 09N61-085 · UDI-DI 00884999050587
PGI
Prescription
1
510(k) clearances
37
Adverse events
2
Recalls
11
Facilities
Description
Alinity m HSV 1 & 2 / VZV CTRL Kit
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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