Devices

COULTER Ac"T" 5diff Fix Reagent.

Model / Serial
Lot # 16602E, 16702E, 16802E
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Botswana, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Guyana, Italy, Japan, Kenya, Mexico, Morocco, Namibia, Netherlands, Nigeria, Philippines, Puerto Rico, Russian Federation, Slovakia, South Africa, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Zambia
Product Description
COULTER¿ Ac"T" 5diff Fix Reagent. || Part Number: 8547171 || COULTER¿ AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of COULTER Ac"T" 5diff Fix Reagent.

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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