Z-1090-2017Class II

cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and...

Name: Z-1090-2017 cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and...
Creator: Roche Diagnostics Corporation
Published: 2016-12-27
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2016-12-27 / Terminated / root cause: software

FDA source

Roche Diagnostics Corporation began a recall of cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis on 2016-12-27. FDA classified it as Class II. As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1090-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-27
Posted: 2017-01-24
Terminated: 2017-08-04
Recalling firm: Roche Diagnostics GmbH
Product: cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Root cause tag: software
FDA 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 [email protected]. " 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
Product codes and lots: Serial Number 63004316 63004416 63004516 63002816 63002916

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1090-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1090-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)