Recall Z-0168-2014— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0168-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-16

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2013-09-16, terminated 2015-05-12. It names one FDA 510(k) clearance: K951595. 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.. Reason: 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.

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-16
Terminated: 2015-05-12
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K951595 — ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESRoche Diagnostic Systems, Inc.·cleared 1995-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.