Recall Z-2257-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
| Date | Aug 23, 2012 (initiated Oct 13, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. |
| Root cause | Software design |
| Action | The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 with attached PCA Response Form to all customers who purchased the UniCel Dxl Immunoassay Systems and DxC Clinical Systems which includes all software versions. The letter describes the product, problem and actions to be taken. The customers were instructed verify the system temperatures immediately following each initialization; do not begin processing samples until this verification is complete; refer to the appendix included with the letter for detailed instructions about verifying system temperat |
| Quantity | 2442 units total (784 units in US) |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel |
| FDA record | Open on fda.gov |