Device Recall UniCel DxH Slidemaker Stainer

Part Number(s) 775222 and A96152; Serial #s-MP010, MP023, MP026, AS23001, AS23002, AS25003, AS25004, AS25005, AS33008, AS33009, AS33010, AS33011, AS37013, AS38014, AS38015, AS39016, AS39017, AS40018, AS44012, AT04001, AT04002, AT04003, AT04004, AT04005, AT22010, AT22011, AT22012, AT35013, AT35014, AT35015, AT35016, AT35017, AT35018, AT40019, AT40020, AT40021, AT40022, AT40023, AT40024, AT40025, AT40026, AT40027, AT40028, AT40029, AT40030, AT45031, AT45032, AT45033, AT45034, AT45035

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-USA (nationwide) including the states GA, NY, IL, TX, WA, PA, IN, MS, NC, and MO and the countries of Belgium, France, Hong Kong, Italy, Spain, and Switzerland.

UniCel DxH Slidemaker Stainer Instrument System, PN 775222. || The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer.

Part Number(s) 775222 and A96152; Serial #s-MP010, MP023, MP026, AS23001, AS23002, AS25003, AS25004, AS25005, AS33008, AS33009, AS33010, AS33011, AS37013, AS38014, AS38015, AS39016, AS39017, AS40018, AS44012, AT04001, AT04002, AT04003, AT04004, AT04005, AT22010, AT22011, AT22012, AT35013, AT35014, AT35015, AT35016, AT35017, AT35018, AT40019, AT40020, AT40021, AT40022, AT40023, AT40024, AT40025, AT40026, AT40027, AT40028, AT40029, AT40030, AT45031, AT45032, AT45033, AT45034, AT45035

Hematology and Pathology Devices

1

No

Worldwide Distribution-USA (nationwide) including the states GA, NY, IL, TX, WA, PA, IN, MS, NC, and MO and the countries of Belgium, France, Hong Kong, Italy, Spain, and Switzerland.

UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. || The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer.