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Coulter HMX Hematology Analyzers and Coulter IH 500 Series System (2014-10-20)
- Starting date:
- October 20, 2014
- Posting date:
- October 29, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41977
Recalled Products
A) Coulter HMX Hematology Analyzers
B) Coulter IH 500 Series System
Reason
Customers have observed that the differential results for coulter 5c abnormal ii cell control recovered an excessive number of incomplete computation (.....) And/or review ("R") flags on the coulter IH 500 series and HMX analyzers. The issue may occur more often when laboratory temperatures fall below 70 degrees Fahrenheit (21 degrees Celsius).
Affected products
A) Coulter HMX Hematology Analyzers
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
6605523
6605526
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B) Coulter IH 500 Series System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
178833
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES