Z-0624-06

In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine...

Name: Z-0624-06 In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine...
Creator: Abbott Health Products, Inc.
Published: 2005-03-23
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2005-03-23 / Terminated / root cause: manufacturing process

FDA source

Abbott Health Products, Inc. began a recall of In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of... on 2005-03-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0624-06
Status: Terminated
Initiated: 2005-03-23
Posted: 2006-03-15
Terminated: 2012-01-27
Recalling firm: Abbott Diagnostic International, Ltd.
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).
Product code: MGU Fluorescence Polarization Immunoassay For Cyclosporine
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.
Root cause tag: manufacturing process
FDA 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 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,
Product codes and lots: Lot 18229Q100 (exp 8/26/2006) Lot 18230Q100 (exp 10/05/2006)

Product code MGU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)