HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling HDL-Cholesterol gen.3 test kits used to measure high-density lipoprotein cholesterol in blood and urine samples. The recall affects 6,255 analytical units distributed nationwide in the US and Puerto Rico. The kits are affected by possible drug interference when used on multiple Cobas Analyzers, which can cause test results to be falsely decreased when samples are collected from patients who recently took Acetaminophen or N-acetylcysteine, or when certain urine tests (Creatinine plus and Uric Acid applications) are run.
The recall involves four catalog numbers: 05401470190, 03263991190, 05168589190, and 03263991190. The source document does not specify what action affected consumers or healthcare providers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US (nationwide) including PR. Quantity: 6255 analytical units Lot/code info: Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.