Recall Z-0800-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
| Date | Jan 21, 2014 (initiated Dec 17, 2013) |
| Status | Terminated |
| Reason | An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result. |
| Root cause | Software design |
| Action | The distribution of the Urgent Medical Device Correction letter scheduled to begin on December 17, 2013. x Field service personnel will be notified of the Urgent Medical Device Correction Letter via the Siemens Knowledge Base, as well as information regarding placing labels on the customer system to remind the customer that ///// is not a reportable result. x The Customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue. x Customers are requested to complete and return the Effectiveness Check questionnair |
| Quantity | 1563 |
| Distribution | Worldwide Distribution. USA nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp., May 21, 1999 |