Roche Acetaminophen Assay Method Sheets Missing Interference Statement
Roche Diagnostics is recalling Acetaminophen assay method sheets for COBAS INTEGRA and MODULAR ANALYTICS systems because they omit a statement regarding potential interference from gammopathy.
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, but the hazard is a documentation error (missing interference statement) rather than a direct physical defect or contamination, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Roche Diagnostics Corporation is recalling method sheets for the Acetaminophen assay used on COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module. The recall involves 35,111 units distributed nationwide.
The recall was initiated because the previous version of the method sheets is missing a specific statement in the Limitations-interference section. The omitted text notes that in very rare cases, gammopathy, particularly type IgM (Waldenström's macroglobulinemia), may cause unreliable results.
Healthcare facilities and laboratories using these specific analyzers and assays should review their documentation to ensure they are using the corrected method sheets that include the interference warning.
The recalled product
- Product
- Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 35,111
Distribution
Distributed nationwide across the United States.
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