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bioMerieux, Inc. recalls VIDAS Lyme IgM II (LYM), REF 416436
Recalled January 5, 2022 · FDA recall Z-0436-2022 · bioMerieux
Hazard
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. · FDA Class II
Units
Three lots
Sold at
US Nationwide distribution.
Description
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.
Product
VIDAS Lyme IgM II (LYM), REF 416436
Manufacturer(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →