FDA-Device2013-07-03Class II
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare ob
Microgenics Corporation
Hazard
It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.
Sold states
Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
Affected count
188
Manufactured in
44660 Osgood Rd, Fremont, CA, United States
Products
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1563-2013Don't want to check this manually?
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