Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit

• • Terminated Z-1944-2020 FDA Class II ·initiated 30 Mar 2020

  A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.

• • Terminated Z-1535-2020 FDA Class II ·initiated 17 Feb 2020

  The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.

• • Terminated Z-0843-2020 FDA Class II ·initiated 7 Nov 2019

  Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.

• • Terminated Z-0913-2020 FDA Class II ·initiated 28 Oct 2019

  Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

• • Terminated Z-1937-2019 FDA Class II ·initiated 18 Oct 2018

  Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.

• • Terminated Z-1894-2018 FDA Class II ·initiated 29 Mar 2018

  The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.

• • Terminated Z-1643-2018 FDA Class II ·initiated 2 Mar 2018

  Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.

• • Terminated Z-1893-2018 FDA Class II ·initiated 4 Dec 2017 ·on shared 510(k) K101852

  A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes.

• • Terminated Z-1384-2017 FDA Class II ·initiated 30 Jan 2017

  The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.

• • Terminated Z-1067-2016 FDA Class II ·initiated 13 Jan 2016

  Iris International noted loose or missing analyte pads found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCITY System.

• • Terminated Z-2441-2015 FDA Class II ·initiated 15 Jul 2015

  Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K101852 ↗

FDA Product Code

KQO

Device Class

Class I

Regulation

21 CFR Part 862.2900

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent