Z-0168-2014 Class II Terminated
FDA device recall Z-0168-2014 was initiated by Roche Diagnostics Operations, Inc. on Sep 16, 2013 and is designated Class II. Reason for recall: Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the… The recall status is terminated (terminated May 12, 2015). Affected quantity: 527 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 13, 2013
- Initiation Date
- Sep 16, 2013
- Termination Date
- May 12, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 527 units
Product Description
COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Reason for Recall
Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof
Distribution Pattern
Nationwide Distribution and Puerto Rico
Code Information
software version 9864.C2
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0168-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026