Recall Z-0723-2017 ยท GKZ Counter, Differential Cell
Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
| Date | Oct 21, 2016 |
| Status | Terminated |
| Reason | Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction Letter HI17-02.A.US (dated October 21, 2016) and Response Form were sent to US Customers via Federal Express. An Urgent Field Safety Notice was sent to customers outside the US on October 21, 2016, (distribution is determined at the country level). The letters instruct customers to contact their local Siemens technical support representative if they obtain multiple results for one Sample ID. It also informs the customer what to do if the ADVIA 560 Hematology System generates any of the six error messages listed in the letter. For further questions, p |
| Quantity | US: 23 systems; Foreign: 141 systems |
| Distribution | Worldwide Distribution - US Distribution to the states of including Puerto Rico and : CA, CO, FL, IL, MI, NJ, NY, OH, TX, WA, WI, WI and WY., and to the countries of : Angola, Australia, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, France, Germany, Greece, India, Ital |
| FDA record | Open on fda.gov |