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Ortho Clinical Diagnostics Inc recalls Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Sy
Recalled February 27, 2019 · FDA recall Z-0844-2019 · Ortho Clinical Diagnostics
Hazard
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration. · FDA Class II
Units
4030
Sold at
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.
Description
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Product
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
Manufacturer(s)
Ortho Clinical Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →