Roche Diagnostics Operations, Inc. recalls LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determinati…

Recall date

May 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1927-2015

FDA classification

Class II

Brand / firm

Roche Diagnostics Operations, Inc.

Sold / distributed

US (nationwide) including PR.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.