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Terminated

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.

FDA Recall Z-2225-2012 · Posted 2012-08-20

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeCKG
Date Initiated2011-12-13
Date Terminated2012-08-20
Product Quantity41 units (15 units in the US)

Reason for Recall

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

Firm Action

Beckman Coulter initiated a "PRODUCT CORRECTIVE ACTION (PCA)" which was communicated via phone calls starting the week of December 19, 2011 to all customers who purchased UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System. The phone calls provided the customers with an explanation of the problem identified, potential impact should the problem occur and an action to be taken. Customers were instructed to share the PCA information with their laboratory staff and if they had any questions, they should contact Beckman Coulter at (800) 526-7694.

Root Cause

Process change control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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