Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1924-2015·Announced 2015-07-08

Roche HDL-Cholesterol gen.3. Recalled for Potential Drug Interference

Roche Diagnostics is recalling HDL-Cholesterol gen.3. reagents due to potential false results caused by drug interference on 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, and the hazard involves potential inaccurate test results due to drug interference, which fits the criteria for moderate severity without reported injuries.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling HDL-Cholesterol gen.3. reagents, which are used for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma. The recall involves 6,255 analytical units 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. 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 should stop using the affected reagents and contact Roche Diagnostics for further instructions. The affected catalog numbers are 05401470190, 03263991190, 05168589190, and 03263991190.

The recalled product

Product: HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-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: 05401470190
03263991190
05168589190
03263991190.

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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