bioMerieux, Inc. Recall 88797
Description: VIDAS DEX@, Dimer Exclusion II, REF 30455-01
bioMerieux, Inc. Recall 88797 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0427-2022 |
Event ID | 88797 |
Event Description | VIDAS DEX@, Dimer Exclusion II, REF 30455-01 |
Product Type | Devices |
Distribution | US Nationwide distribution. |
Quantity | 1579 |
Recall Reason | bioMerieux 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 Classification | 20220105 |
Device Code Info | UDI 03573026387006, Lot #s: 1008696660,1008761020, 1008864290, 1008891690 |
Center Classification Date | 20211228 |
Recall Initiation Date | 20210922 |
Recalling Firm | bioMerieux, Inc. |
Initial Notification | |
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