Device Recall TDx/TDxFlx Cyclosporine Monoclonal Whole Blood Calibrators & Controls

Lot 18229Q100 (exp 8/26/2006) Lot 18230Q100 (exp 10/05/2006)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide, Puerto Rico, Hawaii, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Canada, Germany, Japan , Singapore, India, Taiwan, Thailand, Korea, Australia, Honduras, and Panama,

In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test || TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. || TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).