medical Class II Updated 2021-10-20

BioMerieux SA recalls MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the

Recalled Product

MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System


Hazard / Issue

Under certain conditions, there is a risk for a false negative result.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2
View official government recall

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