Z-0100-2017Class II

Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use

Name: Z-0100-2017 Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use
Creator: Roche Diagnostics Operations, Inc.
Published: 2016-07-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2016-07-15 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a... on 2016-07-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0100-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-15
Posted: 2016-10-25
Terminated: 2017-06-05
Recalling firm: Roche Diagnostics GmbH
Product: Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: design
FDA root 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
Product codes and lots: Not applicable

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0100-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0094-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0095-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0096-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0097-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0098-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0099-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0100-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0101-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0102-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0103-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0104-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0105-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0106-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0107-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0108-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0109-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25
Z-0110-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-25

Product code JJE

K951595Class IIRoche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. / cleared 1995-09-08

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)