Class 2 Device Recall Roche cobas p 612 PreAnalytical Instrument calculator

• Date Initiated by Firm: July 15, 2016
• Create Date: October 25, 2016
• Recall Status: Terminated on June 05, 2017
• Recall Number: Z-0106-2017
• Recall Event ID: 75186
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module.
• Code Information: Not applicable
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Roche Support Network Customer Support C; 800-428-2336
• Manufacturer 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.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 9014 in total
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.