Roche Diagnostics Operations, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0101-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 15, 2016

Date Posted: November 2, 2016

Recall Number: Z-0101-2017

Event ID: 75186

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.

Status: Terminated

Product Quantity: 9014 in total

Code Information:

Not applicable

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated