Z-0101-2017 Class II Terminated
FDA device recall Z-0101-2017 was initiated by Roche Diagnostics Operations, Inc. on Jul 15, 2016 and is designated Class II. Reason for recall: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to… The recall status is terminated (terminated Jun 5, 2017). Affected quantity: 9014 in total.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 2, 2016
- Initiation Date
- Jul 15, 2016
- Termination Date
- Jun 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9014 in total
Product Description
cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, In addition, the analyzer determines specific gravity, color, and clarity. The URISYS 2400 is intended for professional use only.
Reason for Recall
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Distribution Pattern
US Nationwide Distribution
Code Information
Not applicable
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0101-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026