Recall Z-2687-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field
| Date | Sep 23, 2014 (initiated Aug 21, 2014) |
| Status | Terminated |
| Reason | Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but wi |
| Root cause | Under Investigation by firm |
| Action | A customer notification letter dated 8/21/14 was sent to all customers who purchased the Sample Probe Cable for use with the UniCel DxI Family of Immunoassay Systems. The letter informs the customers of the problems identified and the actions to be taken. Customer are instructed to complete and return the enclosed response form within 10 days. Customers are instructed to call (800) 854-3633 in US and Canada. |
| Quantity | 236 units total (70 units in US) |
| Distribution | Nationwide in US and worldwide: Canada, China, Colombia, Croatia, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Philippines, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc., Jan 28, 2003 |
| K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS Beckman Coulter, Inc., Nov 12, 2004 |
| K121790 | ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM Beckman Coulter, Inc., Sep 25, 2013 |