FDA-Device2016-11-02Class III
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been es
Ortho-Clinical Diagnostics
Hazard
The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance.
Sold states
Worldwide Distribution-USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Affected count
1,621 units
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0313-2017Don't want to check this manually?
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