Device 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.
Z-1927-2015
Product summary
- Event
- Event 71182
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6255
- Official record key
device-enforcement:Z-1927-2015
Official wording
Reason: 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.
Code information: Catalog numbers 04714423190; 04711220190; 05230438190; 05230446190.
Distribution pattern: US (nationwide) including PR.
Derived failure modes
-
Unknown
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.