Recall Z-2310-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
| Date | Aug 1, 2016 (initiated Jul 30, 2015) |
| Status | Terminated |
| Reason | Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode. |
| Root cause | Nonconforming Material/Component |
| Action | In March 2011, the material and molding process of the Coolant cup (C cup) was changed. BEC did not issue a customer notification letter, as we do not believe that a notificationletter was either warranted or of any potential use or value to our customers, because the coolant cup (C cup) is an internal component that only a BEC Field Service Engineer (FSE) can access and inspect i.e., the C cup is not in a customer-accessible part of the analyzer. Thus, there are no specific actions the customer could take to inspect, identify, or mitigate the potential for a crack or leakage of the C cup. |
| Quantity | 2,130 units total (588 units in US) |
| Distribution | Worldwide Distribution - US (nationwide (including Guam and Puerto Rico), and Internationally to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ec |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112412 | AU5800(R) CHEMISTRY ANALYZER Beckman Coulter, Inc., Dec 23, 2011 |