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Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro qu
Recalled January 21, 2015 · FDA recall Z-0969-2015 · Ortho-Clinical Diagnostics
Hazard
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration. · FDA Class II
Units
1830 Total: USA - 877, Foreign - 953
Sold at
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Description
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
Product
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →