The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1921-2015·Announced 2015-07-08

Roche Cholesterol Gen.2 Cassette Recalled for Potential Drug Interference

Roche Diagnostics is recalling Cholesterol Gen.2 cassettes because Trinder reaction tests may yield falsely decreased results when specific drugs are present.

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 (falsely decreased) due to drug interference rather than direct physical injury or reported illnesses, fitting the criteria for a moderate risk of adverse health consequences through misdiagnosis.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling the Cholesterol Gen.2 cassette (CHOL2), an in vitro diagnostic reagent system used for the quantitative determination of total cholesterol in serum and plasma. The product is intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems.

The recall is issued due to possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Specifically, 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.

A total of 6,255 analytical units were distributed nationwide in the United States, including Puerto Rico. Affected catalog numbers include 04718917190, 03039773190, and 05168538190. Healthcare facilities and laboratories should contact Roche Diagnostics for further instructions on handling the recalled product.

The recalled product

Product
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum…
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
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: 04718917190
  • 03039773190
  • 05168538190
  • 03039773190.

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 →

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