cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
This recall has been terminated (originally issued January 24, 2017).
- Company
- Roche Diagnostics Corporation
- Recall Initiated
- December 27, 2016
- Posted
- January 24, 2017
- Terminated
- August 4, 2017
- Recall Number
- Z-1090-2017
- Quantity
- 5
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Distribution
TX and WA
Lot / Code Info
Serial Number 63004316 63004416 63004516 63002816 63002916
Root Cause
Software design
Action Taken
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.