Chrysalis Intelligence · Sponsors · Biomerieux Sa, Inc.

Biomerieux Sa, Inc.

Hazelwood, MO, US · 1 510(k) clearances · 2 recalls

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Total clearances

1

2023-03-09 → 2023-03-09

Last 12 months

0

Product codes

1

Most recent

2023-03-09

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Class II	Microbiology	1	2023-03-09

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

0

Most recent

2021-09-02

Date	Severity	Status	Recall #	Product	Code	Reason
2021-09-02	Class II	Terminated	Z-0084-2022	MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System	—	Under certain conditions, there is a risk for a false negative result.
2021-06-22	Class II	Terminated	Z-2225-2021	MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results …	—	Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2023-03-09	K222430	VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin	LON	Class II	Microbiology