Home / Recalls / Medical Devices
Roche Diagnostics Operations, Inc. recalls COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 0458
Recalled November 13, 2013 · FDA recall Z-0168-2014 · Roche Diagnostics Operations
Hazard
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 · FDA Class II
Units
527 units
Sold at
Nationwide Distribution and Puerto Rico
Description
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
Product
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.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →