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: - 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)
Recall
- Recall Number
- Z-2128-2011
- Event Number
- 58287
- Firm
- Beckman Coulter Inc.
- FEI Number
- 2050012
- Product Code
- GKZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 20, 2010
- Posted
- May 2, 2011
- Terminated
- September 2, 2014
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232
Description
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: - 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)
Body Fluids results may be incorrectly interpreted by the Laboratory Information System (LIS). Body Fluid results ~ 1,000 celis/uL are reported using the US numeric separators to demark thousandths places (comma, ",") and partial units (decimal, "."). An LIS that uses non-US formats could interpret the comma as a partial units separator, which could lead to reporting erroneously low body fluid r
The firm, Beckman Coulter, issued an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010, with PCA Response Form to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Remove all cassettes from the mix station prior to initiating the Diluent Dispense function. Do not initiate Diluent Dispense while specimens are being processed in cassette presentation. 2)Do not use pre-diluted samples for RETIC counts. The instrument is validated for pre-diluted CBC's only, as indicated in the Instructions for Use (IFU). 3)Verify that their information Technology personnel are aware that the Body Fluids data string is only transmitted to the LIS using the US numeric separators and that the Body Fluid results are properly validated at the LIS. 4) Use the lip on the reagent drawer to move the drawer as shown. Avoid touching the drawer slides while replacing containers. Clean all spills promptly to reduce the risk of exposure to blood borne pathogens. 5)Complete and return the enclosed PRODUCT CORRECTIVE RESPONSE FORM within 10 days, share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation. Beckman Coulter will make corrections in future version software. Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees/customers local Beckman Coulter representative.
Worldwide distribution: USA (nationwide) and countries including: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.
422 units in total (175 in US)