FDAApril 26, 2021device
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.
What to do
FDA enforcement status: Ongoing
Brands named
roche diagnostics operationsrocheroche diagnostics
UPCs
0401563091890403183696122
Recall history
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