Recall Z-1233-2016 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Operations, Inc.
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
| Date | Feb 23, 2016 |
| Status | Terminated |
| Reason | Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material. |
| Root cause | Software design |
| Action | Roche Diagnostics sent an "Urgent Medical Device Correction" letter via UPS Ground (receipt required) on February 23, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To prevent this malfunction, a software patch has been developed and validated. The installation of this software patch is mandatory and will be performed by a Roche Field Engineering Specialist (FES). Your Roche FES will contact you to schedule the installation of the software patch. Until the software patch is implemented, Roche recommends that i |
| Quantity | 35 Units |
| Distribution | US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.