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Hmx Hematology Analyzer and Coulter Lh Analyzers (2017-06-19)
- Starting date:
- June 19, 2017
- Posting date:
- July 11, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-63894
Affected Products
A. Hmx Hematology Analyzer
B. Coulter Lh 780 Analyzer
C. Coulter Lh 750 Analyzer
D. Coulter Lh 500 Analyzer
Reason
Beckman Coulter has determined that additional clarification for the blast suspect messages is necessary. In rare situations, the LH750, LH780, LH500 and HMX analyzers may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as the properties of blasts in certain samples.
Affected products
A. Hmx Hematology Analyzer
Lot or serial number
All lots
Model or catalog number
6605523
6605526
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. Coulter Lh 780 Analyzer
Lot or serial number
All lots
Model or catalog number
723585
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
C. Coulter Lh 750 Analyzer
Lot or serial number
All lots
Model or catalog number
6605632
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
D. Coulter Lh 500 Analyzer
Lot or serial number
All lots
Model or catalog number
178833
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES