Health product recall

iChemVELOCITY Automated Urine Chemistry System - with Load/Unload and Back Integrated, iRICELL1000 Plus, iRICELL2000 Plus and Pro, iRICELL3000 Plus and Pro (2018-02-26)

Starting date:
February 26, 2018
Posting date:
April 3, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66318

Affected products

  1. iChemVELOCITY Automated Urine Chemistry System
  2. ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD
  3. ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM BACK INTEGRATED
  4. IRICELL 2000 PRO
  5. IRICELL 2000 PLUS
  6. IRICELL 3000 PLUS
  7. IRICELL 3000 PRO
  8. IRICELL 1000 PLUS

Reason

Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers.

  • The installation of international settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations.
  • 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.

Affected products

  1. iChemVELOCITY Automated Urine Chemistry System

Lot or serial number

All lots.

Model or catalog number

800-7719

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


B. ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD

Lot or serial number

All lots.

Model or catalog number

800-7167

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


C. ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM BACK INTEGRATED

Lot or serial number

All lots.

Model or catalog number

800-7720

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


D. IRICELL 2000 PRO

Lot or serial number

All lots.

Model or catalog number

800-3049

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


E. IRICELL 2000 PLUS

Lot or serial number

All lots.

Model or catalog number

800-7714

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


F. IRICELL 3000 PLUS

Lot or serial number

All lots.

Model or catalog number

800-3079

800-7713

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


G. IRICELL 3000 PRO

Lot or serial number

All lots.

Model or catalog number

800-3050

800-3080

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


H. IRICELL 1000 PLUS

Lot or serial number

All lots.

Model or catalog number

800-7715

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES