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bioMerieux, Inc. Recall 90605

Page Last Updated: November 19, 2022

Description: VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9

bioMerieux, Inc. Recall 90605 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1640-2022
Event ID90605
Event DescriptionVITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Product TypeDevices
DistributionInternational distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.
Recall ReasonThere are 7 reported software anomalies that may affect use of the device.
Device Classification20220907
Device Code InfoVITEK 2 Software Versions 8.01, 8.02 (veterinary only), 9.01, 9.02, 9.03 / MYLA Software Versions V4.8, V4.9 UDI/GTIN: 03573026553968, 03573026619060, 03573026609399, 03573026613914, 03573026619244, 03573026621568
Center Classification Date20220826
Recall Initiation Date20220713
Recalling FirmbioMerieux, Inc.
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