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
- IQ 200 SPRINT AUTOMATED URINE MICROSCOPY ANALYZER
- IQ200 SELECT URINALYSIS SYSTEM - ANALYZER
- IQ 200 ELITE AUTOMATED URINE MICROSCOPY ANALYZER
- IQ 200 ELITE PLUS
- IQ 200 ELITE PRO
- IQ 200 SELECT PRO
- IQ 200 SELECT PLUS
- IQ 200 SPRINT PRO
- 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
-
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