Health product recall

iQ200 Sprint and Elite Automated Urine Microscopy Analyzer, iQ200 Select Urinanlysis System - Analyzer, iQ200 Elite Plus and Pro, iQ Select Plus and Pro, iQ Sprint 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-66308

Affected products

  1. IQ 200 SPRINT AUTOMATED URINE MICROSCOPY ANALYZER
  2. IQ200 SELECT URINALYSIS SYSTEM - ANALYZER
  3. IQ 200 ELITE AUTOMATED URINE MICROSCOPY ANALYZER
  4. IQ 200 ELITE PLUS
  5. IQ 200 ELITE PRO
  6. IQ 200 SELECT PRO
  7. IQ 200 SELECT PLUS
  8. IQ 200 SPRINT PRO
  9. IQ 200 SPRINT PLUS

Reason

Beckman coulter has determined that there is a potential for under-reporting casts. This can occur if per High-Power Field (HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting "per Low-Power Field (LPF)" or “per microliter (ul)”. This may occur during initial method validation or if settings are altered after the initial validation.

Affected products

  1. IQ 200 SPRINT AUTOMATED URINE MICROSCOPY ANALYZER

Lot or serial number

All lots.

Model or catalog number

700-3322

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


B. IQ200 SELECT URINALYSIS SYSTEM - ANALYZER

Lot or serial number

All lots.

Model or catalog number

800-3900

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


C. IQ 200 ELITE AUTOMATED URINE MICROSCOPY ANALYZER

Lot or serial number

All lots.

Model or catalog number

800-3920

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


D. IQ 200 ELITE PLUS

Lot or serial number

All lots.

Model or catalog number

800-3934

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


E. IQ 200 ELITE PRO

Lot or serial number

All lots.

Model or catalog number

800-3052

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


F. IQ 200 SELECT PRO

Lot or serial number

All lots.

Model or catalog number

800-3051

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


G. IQ 200 SELECT PLUS

Lot or serial number

All lots.

Model or catalog number

800-3935

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


H. IQ 200 SPRINT PRO

Lot or serial number

All lots.

Model or catalog number

800-3053

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES


I. IQ 200 SPRINT PLUS

Lot or serial number

All lots.

Model or catalog number

800-3933

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

UNITED STATES