Z-1923-2015 Class II Terminated
FDA device recall Z-1923-2015 was initiated by Roche Diagnostics Operations, Inc. on May 7, 2015 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Mar 24, 2017). Affected quantity: 6,255 analytical units distributed.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 8, 2015
- Initiation Date
- May 7, 2015
- Termination Date
- Mar 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,255 analytical units distributed
Product Description
Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Reason for Recall
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.
Distribution Pattern
US (nationwide) including PR.
Code Information
Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1923-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026