Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers t...
FDA Recall #Z-0800-2014 — Class II — December 17, 2013
Product Description
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Newark, DE
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1563
Distribution
Worldwide Distribution. USA nationwide and the country of Canada.
Code Information
ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated