Z-0436-2022 Class II Ongoing
FDA device recall Z-0436-2022 was initiated by bioMerieux, Inc. on September 22, 2021 and is designated Class II. Reason for recall: 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 r… The recall status is ongoing. Affected quantity: Three lots.
Recall Details
- Product Type
- Devices
- Report Date
- January 5, 2022
- Initiation Date
- September 22, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Three lots
Product Description
VIDAS Lyme IgM II (LYM), REF 416436
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI 03573026447151, Lot #: 1008636750, 1008768920, 1008857410