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U.S. Department of Health and Human Services

Class 2 Device Recall cobas p 612 preanalytical system

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  Class 2 Device Recall cobas p 612 preanalytical system see related information
Date Initiated by Firm December 27, 2016
Date Posted January 24, 2017
Recall Status1 Terminated 3 on August 04, 2017
Recall Number Z-1090-2017
Recall Event ID 76078
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product cobas p 612 pre-analytical system;

Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
Code Information Serial Number 63004316 63004416 63004516 63002816 63002916 
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support C
800-428-2336
FDA Determined
Cause 2		 Software design
Action On 12/27/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected Consignees via courier fax or email. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The cobas p 612 pre-analytical system (63x) software is being revised to correct the aspiration process. We anticipate this new version (2.0.4) to be available during Quarter 1 2017. For now, discontinue using disposable non-filter tips for Aliquotting on your cobas p 612 pre-analytical system (63x). You will be contacted by a Roche Field Engineering Specialist (FES) about modifying your system to allow for the use of disposable filter tips. Filter tips will be provided at the time of service. Actions Required " Immediately discontinue using disposable non-filter tips for Aliquotting on your cobas p 612 pre-analytical system (63x). " Complete the enclosed faxback form and fax it to number 1-877-906-8982 or email it to Indianapolis.cd_tsc@roche.com. " Provide copies of this UMDC to other clinicians who may need to be aware of this software issue. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center at 1-800-428-2336, 24 hours a day/7 days a week, if you have questions about the information contained in this UMDC.
Quantity in Commerce 5
Distribution TX and WA
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.
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