Device product
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Z-1922-2015
Product summary
- Event
- Event 71182
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,255 analytical units distributed
- Official record key
device-enforcement:Z-1922-2015
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: 11775685216; 11875566216; 11875582216.
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.