Recall Z-0914-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- For in vitro diagnostic use only. The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative me
| Date | Jan 26, 2012 (initiated Apr 28, 2011) |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics received complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges, Models 4815, 4816 and 4817, that may be configured with enGen(TM) Laboratory Automation Systems. |
| Root cause | Component design/selection |
| Action | Ortho-Clinical Diagnostics sent an Urgent Product Correction Notification letter dated April 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to post the enclosed attachment near their centrifuge as a reference. Clean and carefully inspect the suspension groove area of the centrifuge buckets for cracks as part of their weekly maintenance procedure. Careful to check for micro-cracks that may not be easily detectable. If any cracks/micro-cracks, corrosion or damage are present, they must |
| Quantity | 78 units worldwide (18 Domestic and 68 Foreign) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM Ortho-Clinical Diagnostics, Inc., Nov 13, 2006 |