FDA Enforcement
Class II
Terminated
Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
Recall: Z-1931-2015
·
Reported July 8, 2015
Enforcement
- Recall Number
- Z-1931-2015
- 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
Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
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:04657608190; 03183807190; 05171857190; 03183807190; 11875426216; 11929429216; 11929437216.
Distribution
US (nationwide) including PR.
Quantity
6255