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Ortho-Clinical Diagnostics recalls VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only
Recalled June 25, 2014 · FDA recall Z-1805-2014 · Ortho-Clinical Diagnostics
Hazard
Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28. · FDA Class II
Units
Domestic - 464 units; Foreign - 361 units
Sold at
Worldwide Distribution-USA (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
Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.
Product
VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →