Devices

COULTER DxH Cell Lyse

Model / Serial
628018, 628019 | 0710001, 0710003, 0711002, 0712001; 0710002, 0710004, 0711001, 0711003, 0712002
Product Description
IVD: Red Cell Lysing Reagent
Manufacturer
Beckman Coulter Inc.
1 Event
- Field Safety Notices about COULTER DxH Cell Lyse

Manufacturer

Beckman Coulter Inc.

Manufacturer Parent Company (2017)
Danaher Corporation
Source
SATP

One device with a similar name

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Device Recall COULTER DxH Cell Lyse

Model / Serial
Lot Numbers: 0710001, 0710003, 0711002, 0712001, 0710002, 0710004, 0711001, 0711003, and 0712002.
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- Australia, Belgium, Brunei Darussalam, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.
Product Description
COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). || The COULTER¿ DxH Cell Lyse is an erythrocyte lytic agent used for quantitative || determination of hemoglobin, enumeration of NRBC, and counting and sizing || leukocytes on UniCel¿ DxH 800 Coulter¿ Cellular Analysis System.
Manufacturer
Beckman Coulter Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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