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Terminated

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC 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

FDA Recall Z-2692-2016 · Posted None

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2016-08-04
Date Terminated2016-10-06
Product Quantity759 units total (358 units in US)

Reason for Recall

Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.

Firm Action

Beckman Coulter sent an Urgent Medical Device recall letter dated August 4, 2016, to all affected customers to inform them that the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the recall notice were instructed to contact Beckman Coulter Customer Support Center: http://www.beckmancoulter.com/customersupport/support; 800-526-7694 in the United States and Canada; and outside the United States and Canada, are instructed to contact their local Beckman Coulter Representative.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait, Malaysia, Mayotte, Mexico, New Zealand, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, and Vietnam.

Official Source

View FDA Recall →

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

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