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bioMerieux, Inc. Recall 88797

Description: VIDAS Lyme IgM II (LYM), REF 416436

bioMerieux, Inc. Recall 88797 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0436-2022
Event ID88797
Event DescriptionVIDAS Lyme IgM II (LYM), REF 416436
Product TypeDevices
DistributionUS Nationwide distribution.
QuantityThree lots
Recall ReasonbioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Device Classification20220105
Device Code InfoUDI 03573026447151, Lot #: 1008636750, 1008768920, 1008857410
Center Classification Date20211228
Recall Initiation Date20210922
Recalling FirmbioMerieux, Inc.
Initial Notification E-Mail
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