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Roche Diagnostics Operations, Inc. recalls HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c
Recalled July 8, 2015 · FDA recall Z-1925-2015 · Roche Diagnostics Operations
Hazard
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. · FDA Class II
Units
6255
Sold at
US (nationwide) including PR.
Description
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.
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.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →