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Recall Observatory FDA recall evidence

Device product

VIDAS Lyme IgM II (LYM), REF 416436

Z-0436-2022

September 22, 2021

Class II

Product summary

Firm
bioMerieux, Inc.
Event
Event 88797
Status
Ongoing
Classification
Class II
Quantity
Three lots
Official record key
device-enforcement:Z-0436-2022

Official wording

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.

Code information: UDI 03573026447151, Lot #: 1008636750, 1008768920, 1008857410

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.