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Terminated

UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)

FDA Recall Z-1980-2011 · Posted 2011-04-14

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2010-10-20
Date Terminated2012-04-02
Product Quantity422 units in total (175 in US)

Reason for Recall

Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers. IMPACT: There is potential for exposure to blood borne pathogens such as HIV, HBV, and HCV.

Firm Action

Beckman Coulter sent an Urgent Product Corrective Action letter dated October 20, 2010, with a PCA Response Form (via US PostalService) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. This letter informed the customers about the problems identified and provided an action/resolution to this issue. Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation. Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter representative

Root Cause

Other

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081930UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMBeckman Coulter, Inc. · 2008-12-19

Official Source

View FDA Recall →

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

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