FDA Recall Terminated

Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.

Recall: Z-0100-2017 · Initiated July 15, 2016

Recall

Recall Number: Z-0100-2017
Event Number: 75186
Firm: Roche Diagnostics Operations, Inc.
FEI Number: 1823260
Product Code: JJE
Status: Terminated
Root Cause: Device Design
Initiated: July 15, 2016
Terminated: June 5, 2017
Address: 9115 Hague Rd, Indianapolis, IN, 46256-1025

Description

Reason

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.

Action

On 7/15/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, an updated cleaning procedure, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this UMDC. On 10/5/2016, URGENT MEDICAL DEVICE CORRECTION UPDATE notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification updated the 7/15/16 notification to include additional affected systems and to provide updated cleaning instructions for all systems via the enclosed Operators Manual addendum.

Distribution

US Nationwide Distribution

Quantity

9014 in total