Roche Triglycerides GPO Test Recalled for Potential Drug Interference
Roche is recalling Triglycerides GPO tests because certain drugs may cause falsely decreased results on specific Cobas 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, but the source text describes a potential for inaccurate test results (falsely decreased) rather than a direct physical injury or hospitalization. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where no specific injury is reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 6,255 units of the Triglycerides GPO in vitro test. This product is used for the quantitative determination of triglycerides in human serum and plasma on COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems. The recall is due to a potential drug interference issue when using the Trinder reaction method on multiple Cobas Analyzers.
The recall is precautionary because results of Trinder tests may be falsely decreased when run with urine samples (specifically for Creatinine plus and Uric Acid applications) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. The affected units were distributed nationwide in the US, including Puerto Rico.
Healthcare facilities and laboratories should stop using the affected products and contact Roche Diagnostics Operations, Inc. for instructions on how to return the units. The affected catalog numbers are 04657594190, 20767107322, 05171407190, 11730711216, 11876023216, 11876040216, and 11488872216.
The recalled product
- Product
- Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 6,255
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 (7)
- Catalog Numbers: 04657594190
- 20767107322
- 05171407190
- 11730711216
- 11876023216
- 11876040216
- 11488872216.
Distribution
Part of a larger recall action
This product is one of 12 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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