Devices

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.
1 Event
- Recall of Device Recall COULTER DxH Cell Lyse

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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