medical Class II Updated 2019-02-27

Ortho Clinical Diagnostics Inc recalls Vitros Myoglobin Calibrators, Product Code 6801043 For use i

Recalled 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


Hazard / Issue

A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)
View official government recall

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