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bioMerieux, Inc. recalls VIDAS TOXO IgG Avidity (TXGA), REF 30222-01

Recalled January 5, 2022 · FDA recall Z-0431-2022 · 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
One lot
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 TOXO IgG Avidity (TXGA), REF 30222-01
Manufacturer(s)
bioMerieux, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

bioMerieux, Inc. recalls VIDAS TOXO IgG Avidity (TXGA), REF 30222-01 | RecallWatchUSA