Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1928-2015·Announced 2015-07-08

Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

Roche Diagnostics is recalling 6,255 units of the LDL-Cholesterol plus gen.2. test due to potential false results caused by drug interference.

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 due to drug interference rather than direct physical injury or reported illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 6,255 units of the LDL-Cholesterol plus gen.2. test. The product is intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma. The recall covers units distributed nationwide in the United States, including Puerto Rico, under catalog numbers 05401682190, 03038866322, and 05171369190.

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 (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.

Healthcare facilities and laboratories that have purchased or received these units should stop using the affected products and contact the recalling firm for instructions on return or replacement.

The recalled product

Product: LDL-Cholesterol plus 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 — 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 (4)

Catalog Numbers 05401682190
03038866322
05171369190
03038866322.

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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