Class 2 Device Recall TDx/TDxFlx Cyclosporine Monoclonal Whole Blood Calibrators & Controls

• Date Initiated by Firm: March 23, 2005
• Date Posted: March 15, 2006
• Recall Status: Terminated on January 27, 2012
• Recall Number: Z-0624-06
• Recall Event ID: 32890
• PMA Number: P890025
• Product Classification: Fluorescence Polarization Immunoassay For Cyclosporine - Product Code MGU
• Product: 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).
• Code Information: Lot 18229Q100 (exp 8/26/2006) Lot 18230Q100 (exp 10/05/2006)
• Recalling Firm/ Manufacturer: Abbott Health Products, Inc.; Hwy 2 Km 58.0; Cruze Davila; Barceloneta PR 00617
• For Additional Information Contact: Nydia I. Cancel; 787-846-3500 Ext. 7350
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 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,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MGU