Skip to content
Recall Observatory FDA recall evidence

Device product

Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.

Z-0800-2014

December 17, 2013

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 67030
Status
Terminated
Classification
Class II
Quantity
1563
Official record key
device-enforcement:Z-0800-2014

Official wording

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.

Code information: ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01

Distribution pattern: Worldwide Distribution. USA nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.