Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
FDA Recall Z-0800-2014 · Posted 2014-01-21
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2013-12-17
Date Terminated2014-08-26
Product Quantity1563
Reason for Recall
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.
Firm 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 questionnaire attached to the Urgent Medical Device Correction.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution. USA nationwide and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.