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BioMerieux SA Recall 88658

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

BioMerieux SA Recall 88658 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0084-2022
Event ID88658
Event DescriptionMYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the countries of Austria, Australia, Belgium, Canada, Switzerland, Chile, Columbia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong, Canary Islands, Ireland, India, Italy, Japan, South Korea, The Netherlands, Norway, Poland, Portugal, Sweden, Singapore, South Africa.
Quantity542 units
Recall ReasonUnder certain conditions, there is a risk for a false negative result.
Device Classification20211020
Device Code InfoMYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2
Center Classification Date20211008
Recall Initiation Date20210902
Recalling FirmBioMerieux SA
Initial Notification Letter
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