Home / Recalls / Medical Devices
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction
Recalled April 30, 2014 · FDA recall Z-1490-2014 · Ortho-Clinical Diagnostics
Hazard
Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC. · FDA Class II
Units
US: 284 units, Ex-US: 4772 units
Sold at
Worldwide Distribution - US Distribution including the states of AR, FL, IA, IL, KY, MI, MN, ND, NY and VA, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Description
Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.
Product
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →