FDA-Device2022-01-05Class II
VIDAS Lyme IgG II (LYM), REF 417401
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
Two lots
Manufactured in
100 Rodolphe St, Durham, NC, United States
Products
VIDAS Lyme IgG II (LYM), REF 417401
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0437-2022Don't want to check this manually?
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