Z-0387-2017Class II

Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use

Name: Z-0387-2017 Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use
Creator: Roche Diagnostics Operations, Inc.
Published: 2016-09-27
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2016-09-27 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro... on 2016-09-27. FDA classified it as Class II and gives the reason as "cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated...". 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-0387-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-27
Posted: 2016-11-10
Terminated: 2017-07-21
Recalling firm: Roche Diagnostics GmbH
Product: Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.
Root cause tag: software
FDA root cause: Software design
Action: Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated September 27, 2016 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. Customers were asked to complete the attached fax form and fax it to 1-866-808-1159. For questions contact the Roche Support Network Customer Support Center at 1-800-428-2336.
Quantity in commerce: 139
Distribution: US Nationwide Distribution
Product codes and lots: 04777433001 Cobas c111 with ISE 04528778001 Cobas c111 without ISE cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0387-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0387-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09

Product code JJE

K071211Class IICobas C 111 AnalyzerRoche Diagnostics / cleared 2007-07-30

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)