Roche Diagnostics Operations, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0099-2017)

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:

URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.

Product Classification:

Class II

Date Initiated: July 15, 2016

Date Posted: November 2, 2016

Recall Number: Z-0099-2017

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