Recall Z-0624-06 ยท MGU Fluorescence Polarization Immunoassay For Cyclosporine
Abbott Health Products, Inc.
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 v
| Date | Mar 15, 2006 (initiated Mar 23, 2005) |
| Status | Terminated |
| Reason | Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. An Important Product Information Letter with technical information regarding the Whole Blood Calibrators and Controls, implementing new internal reference standards was issued. |
| Root cause | Other |
| Action | Abbott has recently implemented new internal reference standards for TDx/TDxFLx Cyclosporine monoclonal Whole Blood Calibrators and Controls. A change in performance is associated with the use of calibrator lots 1829Q100 and higher and control lots 18230Q100 and higher, which are the first lots manufactured using the new internal reference standards. The specific performance changes are identified in the letter, dated March 23, 2005, as compared to current product using the previous standards (calibrators lot 05434Q100 and control lot 03071Q100). |
| Quantity | 4,514 kits were distributed |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.