FDA-Device2012-11-28Class III
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .
Microgenics Corporation
Hazard
In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
Sold states
Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
Affected count
2076 total in US , 596 total Foreign
Manufactured in
44660 Osgood Rd, N/A, Fremont, CA, United States
Products
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0379-2013Don't want to check this manually?
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