medical Class II Updated 2021-06-02

Roche Diagnostics Operations, Inc. recalls IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES,

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 04015630918904
View official government recall

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