Roche COBAS INTEGRA c111 recallZ-0387-2017 · Roche Diagnostics Operations, Inc. · initiated Sep 27, 2016
Class II Terminated All recalls posted in November 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0387-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 27, 2016
- Posted by the FDA
- Nov 10, 2016
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 139
- Product code
- JJE
- FDA submissions
- K071211
- Distribution
- US Nationwide Distribution
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
2 devices cleared under K071211 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Glucose HK 4657527190Roche Diagnostics GmbH · HEXOKINASE, GLUCOSE7 reports
- ISE Sodium Electrode 4838084001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, SODIUM3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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