FDA Enforcement
Class II
Terminated
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Recall: Z-1922-2015
·
Reported July 8, 2015
Enforcement
- Recall Number
- Z-1922-2015
- Event ID
- 71182
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Diagnostics Operations, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 8, 2015
- Initiation Date
- May 7, 2015
- Classification Date
- June 27, 2015
- Termination Date
- March 24, 2017
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025, United States
Description
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
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 Info
Catalog Numbers: 11775685216; 11875566216; 11875582216.
Distribution
US (nationwide) including PR.
Quantity
6,255 analytical units distributed