Recall Z-0103-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Operations, Inc.
VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
| Date | Jul 15, 2016 |
| Status | Terminated |
| Reason | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Root cause | Device Design |
| Action | On 7/15/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, an updated cleaning procedure, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this UMDC. On 10/5/2016, URGENT MEDICAL DEVICE CORRECTION UPDATE notifications were sent to the affected customers via courier |
| Quantity | 9014 in total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.