—#98780

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: Specimen tubes may fall out of a Type A cassette (PN A53551, kit of 20) when the analyzer inverts the cassette in the mixing station, or when an operator manually inverts a cassette The impact: - Specimen tubes may fall out of cassettes and be misplaced inside the instrument - Specimen tubes may break upon impact, causing possible biohazard exposure - Patien

Root cause (FDA determination)

Pending

Action the firm took

Beckman Coulter initiated a Product Corrective Action (PCA) letter with attached Recall Response Form being sent via US Postal Service on February 11, 2011 to all customers who have the affected instruments. Customers were informed of the reasons for recall, products affected and resolution for these issues would be corrected in a future release(s) for the DxH 800; but were also asked to take the following actions: -Periodically inspect the mix station drip tray for misplaced tubes that may have fallen from the cassette. - Periodically examine the Type A cassettes to determine if the expandable grippers (clips) within the lavender-colored insert are stuck in the open position (tubes will be loose). Consignees were told to contact their Beckman Coulter representative for assistance with questionable grippers. - Clean any spills according to their laboratory standard operating procedures. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with their laboratory staff and retain the notification as part of their 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: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

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

Timeline

Recall initiated: 2011-02-11
Posted by FDA: 2011-05-10
Terminated: 2012-11-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98780. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.