Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-0844-2019

U.S. FDA — Device Enforcement · United States · 2018-11-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0844-2019
Date of alert
2018-11-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho Clinical Diagnostics Inc
Product category
device
Product type
Devices
Reported risk: A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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