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bioMerieux, Inc. recalls VIDAS SARS-COV-2 IgG, Ref 423834-01
Recalled January 5, 2022 · FDA recall Z-0439-2022 · 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
Two 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 SARS-COV-2 IgG, Ref 423834-01
Manufacturer(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →