FDA-Device2019-02-27Class II
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
Ortho Clinical Diagnostics Inc
Hazard
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Sold states
Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.
Affected count
4030
Manufactured in
1001 US Highway 202, Raritan, NJ, United States
Products
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0844-2019Don't want to check this manually?
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