Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0800-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 17, 2013

Date Posted: January 29, 2014

Recall Number: Z-0800-2014

Event ID: 67030

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.

Status: Terminated

Product Quantity: 1563

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.

Voluntary or Mandated:

Voluntary: Firm initiated