FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corporation: cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
- Recall number
- Z-1090-2017
- Recalling firm
- Roche Diagnostics Corporation
- Product
- cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
- Status
- Terminated
- Initiated
- 2016-12-27
- Posted
- 2017-01-24
- Terminated
- 2017-08-04
- Reason
- not on file
- Root cause
- 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
- 5
- Distribution
- TX and WA
- Lot, serial or model codes
- Serial Number 63004316 63004416 63004516 63002816 63002916
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28