Z-0387-2017 Class II Terminated
FDA device recall Z-0387-2017 was initiated by Roche Diagnostics Operations, Inc. on Sep 27, 2016 and is designated Class II. 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. … The recall status is terminated (terminated Jul 21, 2017). Affected quantity: 139.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2016
- Initiation Date
- Sep 27, 2016
- Termination Date
- Jul 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139
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.
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.
Distribution Pattern
US Nationwide Distribution
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0387-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026