Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1927-2015·Announced 2015-07-08

Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

Roche Diagnostics is recalling the LDL-Cholesterol gen.2 test because certain drugs may cause falsely decreased results when using 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard involves potential inaccurate test results due to drug interference rather than direct physical injury or death.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 6,255 units of the LDL-Cholesterol gen.2 test. This product is intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma. The recall covers catalog numbers 04714423190, 04711220190, 05230438190, and 05230446190.

The recall is due to a possible drug interference issue when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when run with urine samples (specifically for Creatinine plus and Uric Acid applications) or with 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 United States, including Puerto Rico. Users should contact Roche Diagnostics Operations, Inc. for further instructions regarding the recall and potential replacement or refund.

The recalled product

Product: LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — Laboratory Test Kit
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 (4)

Catalog numbers 04714423190
04711220190
05230438190
05230446190.

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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