Roche Lactate Reagent Recalled for Potential Drug Interference
Roche Diagnostics is recalling Lactate reagent due to potential false results caused by drug interference with the Trinder reaction method.
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 involves potential inaccurate test results (false decreases) rather than direct physical injury or reported illness, fitting the criteria for moderate severity involving low-risk contamination or labeling/functional errors.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 6,255 units of Lactate reagent. The product is intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasma and cerebrospinal fluid.
The recall was initiated because of possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when run with urine samples (Creatinine plus and Uric Acid applications only) 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. Affected catalog numbers include 11822837190, 05401666190, 03183700190, and 05171881190. Users should contact Roche Diagnostics for further instructions regarding the return or replacement of these units.
The recalled product
- Product
- Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
- 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 (5)
- Catalog Numbers: 11822837190
- 05401666190
- 03183700190
- 05171881190
- 03183700190.
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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