Recall Z-2225-2012— Beckman Coulter Inc.

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2011-12-13, terminated 2012-08-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers whic.

Recalling firm

Beckman Coulter Inc.

Classification

Class II

Status

Terminated

Initiated

2011-12-13

Terminated

2012-08-20

Firm location

Brea, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.