—#98954

Product

UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. 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 a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K081930
Affected lot / code info: All Serial Numbers are affected.

Why it was recalled

The recall was initiated because the DxH 800 may fail to meet the carryover specification for the WBC Differential (DIFF) when the WBC is greater than 70 X 10 to the 3rd power cells/micro L (70 X 10 to the 9th power cells/L). Beckman Coulter indicated the DIFF% carryover is unlikely to have clinical impact.

Root cause (FDA determination)

Other

Action the firm took

Beckman Coulter sent a Product Corrective Action (PCA) letter with attached Recall Response Form via US Postal Service on February 11, 2011, to all customers who have the affected instruments. Consignees were informed of the reasons for recall, the products affected and that a resolution for these issues would be corrected in a future release(s) for the DxH 800. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with your laboratory staff and retain this notification as part of your Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, Consignees were told to contact Beckman Coulter, Customer Service at (800) 526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Class 2 Recall - Worldwide Distribution -- USA, and the countries of : Canada, Australia, Macao, Belgium, Malaysia, Colombia, Myanmar, Croatia, Netherlands, Czech Republic, Norway, France, Philippines, Germany, Puerto Rico, Greece, Qatar,Hong Kong, Russian Federation, Hungary, Saudi Arabia, India, Singapore, Spain, Israel, taly Sweden, Japan, Switzerland, Korea, Turkey and United Kingdom.

Timeline

Recall initiated: 2011-02-11
Posted by FDA: 2011-05-05
Terminated: 2014-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98954. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.