FDA-Device2022-01-05Class II
VIDAS Lyme IgM II (LYM), REF 416436
bioMerieux, Inc.
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.
Sold states
US Nationwide distribution.
Affected count
Three lots
Manufactured in
100 Rodolphe St, Durham, NC, United States
Products
VIDAS Lyme IgM II (LYM), REF 416436
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0436-2022Don't want to check this manually?
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