Recall Z-0011-2014 ยท GKZ Counter, Differential Cell
Siemens Healthcare Diagnostics
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
| Date | Oct 17, 2013 (initiated Aug 12, 2013) |
| Status | Terminated |
| Reason | Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information. |
| Root cause | Software design |
| Action | Siemens sent an Urgent Medical Device Correction Letter dated August 8, 2013, and Effectiveness Checks Forms were sent to customers on August 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised if they do not have an ADVIA Autoslide connected to their system, no action is required. To avoid the possibility of mislabeling a slide when an ADVIA 2120/2120i rack jam error occurs: Eject the sample rack. Troubleshoot and correct the reason for the rack jam error. Rerun the sample rack. Fie |
| Quantity | 311 units total (US: 51 units; Foreign: 260 units) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Portugal, South Korea, Singapore, Slovenia, Spain, Switzerland, Thailand, Turkey, United Kingdom an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102644 | ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I Siemens Healthcare Diagnostics, Nov 23, 2011 |