Device 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.
Z-1926-2015
Product summary
- Event
- Event 71182
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6255
- Official record key
device-enforcement:Z-1926-2015
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: 11822837190; 05401666190; 03183700190; 05171881190; 03183700190.
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.