Roche Diagnostics Operations, Inc.: Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are 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.; Possible drug interference when using the Trinder reaction method on multiple Cobas Analy

Agency Publication Date: June 27, 2015

Affected Products

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.

Catalog Numbers: 11491458216; 11875540216; 11875523216.

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 and plasma.

Catalog Numbers: 04718917190; 03039773190; 05168538190; 03039773190.

Product: Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

Catalog Numbers: 11775685216; 11875566216; 11875582216.

Product: Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.

Product: HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.

Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.

Product: HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.

Catalog Numbers: 05401488190; 0439980319; 05168805190; 04399803190, 04878205160.

Product: Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.

Catalog Numbers: 11822837190; 05401666190; 03183700190; 05171881190; 03183700190.

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.

Catalog numbers 04714423190; 04711220190; 05230438190; 05230446190.

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.

Catalog Numbers 05401682190; 03038866322; 05171369190; 03038866322.

Product: Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.

Catalog Numbers: 04657594190; 20767107322; 05171407190; 20767107322; 11730711216; 11876023216; 11876040216; 11488872216.

Product: Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.

Catalog Numbers:11877771216; 11877780190; 11877798190; 05976006190.

Product: Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.

Catalog Numbers:04657608190; 03183807190; 05171857190; 03183807190; 11875426216; 11929429216; 11929437216.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71182

Status: Resolved

Manufacturer: Roche Diagnostics Operations, Inc.

Manufactured In: United States

Units Affected: 12 products (6,255 analytical units distributed; 6,255 analytical units distributed; 6,255 analytical units distributed; 6,255 analytical units distributed; 6255 analytical units; 6255; 6255; 6255; 6255; 6255; 6255; 6255)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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