Roche Diagnostics Operations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0168-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 16, 2013

Date Posted: November 13, 2013

Recall Number: Z-0168-2014

Event ID: 66239

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

Status: Terminated

Product Quantity: 527 units

Code Information:

software version 9864.C2

Distribution Pattern:

Nationwide Distribution and Puerto Rico

Voluntary or Mandated:

Voluntary: Firm initiated