Roche Recalls Iron Gen 2 Reagent Cassettes Due to Discrepant Results
Roche Diagnostics is recalling 20,468 Iron Gen 2 reagent cassettes because they may produce discrepant elevated results on specific analyzers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 20,468 kits of Iron Gen 2 reagent cassettes (Catalog # 03183696122). These in vitro diagnostic products are used for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
The recall was initiated after Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 assay. The affected analyzers include the cobas c311, 501, and 502, as well as the COBAS Integra 400 plus analyzer.
The product was distributed nationwide across the United States, including all 50 states, the District of Columbia, Puerto Rico, and Guam. Users of these reagent cassettes should stop using the product and contact Roche Diagnostics for further instructions.
The recalled product
- 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.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 20,468
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 04015630918904
Distribution
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