Elecsys 2010 Analyzer

• • Terminated Z-0499-2018 FDA Class II ·initiated 5 Jul 2017

  A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.

• • Terminated Z-0095-2017 FDA Class II ·initiated 15 Jul 2016

  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-1790-2014 FDA Class II ·initiated 21 May 2014

  Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

• • Terminated Z-1218-2012 FDA Not yet classified ·initiated 31 Jan 2012

  Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring range. Incorrect but believable results may occur for the CEA, Rubella IgG or SHBG assays. The other affected assays will generate either no value or a negative result, both of which are not bel

• • Terminated Z-0165-2009 FDA Unclassified (pre-2012) ·initiated 24 Jun 2008

  A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.

• • Terminated Z-0868-2008 FDA Unclassified (pre-2012) ·initiated 21 Mar 2008

  Possible mismatch between patient and result.

510(k) Number

K961481 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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