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bioMerieux, Inc. Recall 88797

Description: VIDAS DEX@, Dimer Exclusion II, REF 30455-01

bioMerieux, Inc. Recall 88797 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0427-2022
Event ID88797
Event DescriptionVIDAS DEX@, Dimer Exclusion II, REF 30455-01
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity1579
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 03573026387006, Lot #s: 1008696660,1008761020, 1008864290, 1008891690
Center Classification Date20211228
Recall Initiation Date20210922
Recalling FirmbioMerieux, Inc.
Initial Notification E-Mail
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