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Ortho-Clinical Diagnostics recalls VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitati
Recalled May 15, 2019 · FDA recall Z-1291-2019 · Ortho-Clinical Diagnostics
Hazard
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems · FDA Class II
Units
62 units
Sold at
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.
Description
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Product
VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →