Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1920-2015·Announced 2015-07-08

Roche Cholesterol Reagent Recalled for Potential Drug Interference

Roche Diagnostics is recalling Cholesterol CHOD-PAP reagents because drug interference may cause falsely decreased test results.

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. The hazard involves potential inaccurate test results due to drug interference, which is a significant quality issue but does not involve direct physical injury or death, fitting the Moderate severity criteria for labeling or performance errors without reported harm.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling Cholesterol CHOD-PAP in vitro diagnostic reagent systems. These products are intended for use on Hitachi systems for the quantitative determination of total cholesterol in serum and plasma. A total of 6,255 analytical units were distributed nationwide in the United States, including Puerto Rico.

The recall is due to a potential for drug interference when using the Trinder reaction method on multiple Cobas Analyzers. The source text notes that 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.

Users of these reagents should contact Roche Diagnostics Operations, Inc. for further instructions on how to proceed with the recall.

The recalled product

Product: Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
drug-interference
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 (3)

Catalog Numbers: 11491458216
11875540216
11875523216.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 12 products in this recall →

Same manufacturer · Roche Diagnostics Operations, Inc.

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