Health product recall

ICHEM Velocity Automated Urine Chemistry Systems (2019-10-23)

Starting date:
October 23, 2019
Posting date:
November 29, 2019
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-71714



Last updated: 2019-12-02

Affected Products

A. ICHEM Velocity Automated Urine Chemistry System

B. ICHEM Velocity Automated Urine Chemistry System W Load/Unload

C. ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM BACK INTEGRATED

D. IQ 200 Elite Plus

E. IQ 200 Elite Pro

F. IQ 200 Select Pro

G. IQ 200 Select Plus

H. IQ 200 Sprint Pro

I. IQ 200 Sprint Pro W Load/Unload

J. IQ 200 Sprint Plus

K. IQ 200 Sprint Plus W Load/Unload

Reason

Customers have reported incidents where two sets of results report the ame specimen identifier (specimen ID) with different results, different medical record number (MRN) and different patient identification (demographics).

Affected products

A. ICHEM Velocity Automated Urine Chemistry System

Lot or serial number

All lots.

Model or catalog number

800-7719

Companies
Manufacturer

Beckman Coulter Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


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 Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


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 Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


D. IQ 200 Elite Plus

Lot or serial number

All lots.

Model or catalog number

800-3934

Companies
Manufacturer

Beckman Coulter Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


E. IQ 200 Elite Pro

Lot or serial number

All lots.

Model or catalog number

800-3052

Companies
Manufacturer

Beckman Coulter Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


F. IQ 200 Select Pro

Lot or serial number

All lots.

Model or catalog number

800-3051

Companies
Manufacturer

Beckman Coulter Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


G. IQ 200 Select Plus

Lot or serial number

All lots.

Model or catalog number

800-3935

Companies
Manufacturer

Beckman Coulter Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


H. IQ 200 Sprint Pro

Lot or serial number

All lots.

Model or catalog number

800-3053

Companies
Manufacturer

Beckman Coulter Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


I. IQ 200 Sprint Pro W Load/Unload

Lot or serial number

All lots.

Model or catalog number

800-3082

Companies
Manufacturer

Beckman Coulter Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


J. IQ 200 Sprint Plus

Lot or serial number

All lots.

Model or catalog number

800-3933

Companies
Manufacturer

Beckman Coulter Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND


K. IQ 200 Sprint Plus W Load/Unload

Lot or serial number

All lots.

Model or catalog number

800-3081

Companies
Manufacturer

Beckman Coulter Ireland, Inc.

Lismeehan, O'Callaghan's Mills

County Clare

IRELAND