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Microgenics Corporation recalls Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for u
Recalled November 28, 2012 · FDA recall Z-0379-2013 · Microgenics
Hazard
In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability. · FDA Class III
Units
2076 total in US , 596 total Foreign
Sold at
Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
Description
In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
Product
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. .
Manufacturer(s)
Microgenics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →