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.
Reported: November 2, 2016 Initiated: July 15, 2016 #Z-0099-2017
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.
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 9014 in total
- Distribution
- US Nationwide Distribution
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 9014 in total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 2, 2016. Severity: Moderate. Recall number: Z-0099-2017.
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