Roche Cobas Integra Analyzer, Reagent Cassettes

• • Ongoing Z-1675-2021 FDA Class II ·initiated 26 Apr 2021 ·via K951595, on the same 510(k)

  Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

• • Terminated Z-0100-2017 FDA Class II ·initiated 15 Jul 2016 ·via K951595, on the same 510(k)

  Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

• • Terminated Z-0168-2014 FDA Class II ·initiated 16 Sep 2013 ·via K951595, on the same 510(k)

  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

• • Terminated Z-0696-2013 FDA Class III ·initiated 19 Nov 2012 ·via K951595, on the same 510(k)

  A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access

• 2 recalls, same reason

  • Terminated Z-0007-2009 FDA Unclassified (pre-2012) ·initiated 11 Jun 2008 ·via K951595, on the same 510(k)
  • Terminated Z-0012-2009 FDA Unclassified (pre-2012) ·initiated 11 Jun 2008

  Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

• • Terminated Z-0667-03 FDA Unclassified (pre-2012) ·initiated 13 Feb 2003 ·via K951595, on the same 510(k)

  After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K951595 ↗

FDA Product Code

CGX

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Abuscreen(R) Radioimmun for Cocaine Metabolite

  Class II

  FDA 510(k) K913722 Active Cleared 10 Sep 1991

• Cobas Core Immunochemistry System

  Class I

  FDA 510(k) K962231 Active Cleared 30 Aug 1996

• Roche Reagent for Apolipoprotein B

  Class I

  FDA 510(k) K910552 Active Cleared 7 May 1991

• Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P

  Class II

  FDA 510(k) K952337 Active Cleared 9 Feb 1996

• Roche Abuscreen Ontrak Pos. Ref. Control-Methadone

  Class I

  FDA 510(k) K930844 Active Cleared 27 Jan 1994

• Ontrak Testcup Amphetamines

  Class II

  FDA 510(k) K962411 Active Cleared 7 Oct 1996

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