Recall Z-2590-2010 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fl
| Date | Sep 30, 2010 (initiated Feb 25, 2010) |
| Status | Terminated |
| Reason | Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number <2760 that have software version 4.9.01 installed and have the VME Motorola ICS board) because they may exhibit issues with stat sample rack loading, causing a possible delay in results. |
| Root cause | Other |
| Action | Beckman Coulter sent an URGENT: FIELD SAFETY NOTICE letter, dated March 25, 2010, to all customers. The letter identified the affected product, the problem, and the actions customers take. Customers were instructed to: if the UniCel DxC system serial number was less than 2760 the customer should contact their local representative to arrange for an upgrade to software version 4.9 build 02. Complete and return the enclosed response form within 10 days of the notice. Share the information with their laboratory staff and retain the notification as part of the Quality System documentation. If af |
| Quantity | 22 |
| Distribution | Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060256 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM Beckman Coulter, Inc., Feb 27, 2006 |