This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
iQ200 Sprint, Select, and Elite Urine Microscopy Analyzers (Pro and Plus) (2017-11-13)
- Starting date:
- November 13, 2017
- Posting date:
- December 21, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65456
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
Iris International has determined that the iQ200 Series Urine Microscopy Analyzer with barcode reader (model NFT-2100), may intermittently exhibit the following:
- Failure to read the urine sample dilution barcode label where it defaults to a dilution factor of 1:1 and does not apply the correct dilution factor.
- Failure to read body fluid dilution barcode label where the rack is rejected and no results are generated.
Affected products
A. IQ 200 SPRINT AUTOMATED URINE MICROSCOPY ANALYZER
Lot or serial number
Not Applicable
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
7345
7369
8581
8682
8969
9624
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
Not Applicable
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
3999
6996
7305
7831
9817
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
3999
6996
7305
7831
9817
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
Not Applicable
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
5883
5938
5985
6215
8057
8089
8324
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
More than 10 numbers, contact manufacturer.
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
More than 10 numbers, contact manufacturer.
Model or catalog number
800-3933
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES