—#100102

Product

Unicel DxH 800 Coulter Cellular Analysis System Product Usage: UniCel DxH 800 Coulter Cellular Analysis System Instructions for Use PN 629743AD 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) (BF).

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K081930
Affected lot / code info: Part Number: 629029

Why it was recalled

The recall was initiated because Beckman Coulter has confirmed that the probe wash collar tubing may become stretched or trapped at the Sample Aspiration Module (SAM) during routine use of single-tube presentation station. When the tension on the tubing is severe, the tubing may not be able to return to its home state and may pull the wash collar out of alignment with the aspirate probe. The misal

Root cause (FDA determination)

Pending

Action the firm took

Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated May 11, 2011 with an attached Product Correction Response Form to all affected customers. The letter provides the customers with an explanation of the problem identified, potential impact should the problem occur and actions to be taken. The letter states that this issue will be corrected in a future hardware release. Customers were instructed to share this information with laboratory staff and retain this notification as part of Quality System documentation. If ownership or location of the analyzer(s) has been transferred to another laboratory, customers were instructed to provide a copy of the letter to that party. Customers were also asked to complete and return the enclosed Response Form within ten (10) days, so Beckman can be assured they have received this important communication. Questions concerning this notice, were directed to the 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: Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Timeline

Recall initiated: 2011-05-09
Posted by FDA: 2011-09-01
Terminated: 2012-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100102. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.