Recall Z-0123-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled 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 fluid (CSF) and whole blood (sample type
| Date | Oct 24, 2012 (initiated Sep 3, 2012) |
| Status | Terminated |
| Reason | Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Bar |
| Root cause | Software change control |
| Action | Beckman Coulter sent an Urgent Field Safety Notice dated August 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their Beckman Coulter Service Representative would contac them to reinstall the software. Customers were asked to complete and return the enclosed Response Form. For questions customers were instructed to call their Customers Support Center on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/SupportRequest. For questions regarding this recall call |
| Quantity | 7 units total (both US and International) |
| Distribution | Worldwide Distribution - USA including TX and OH. Interntionally to China and Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS Beckman Coulter, Inc., Nov 12, 2004 |
| K060256 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM Beckman Coulter, Inc., Feb 27, 2006 |
| K103842 | UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 Beckman Coulter, Inc., Apr 27, 2011 |