Recall Z-0723-04 ยท JFT Fluorometric, Cortisol
Abbott Laboratories HPD/ADD/GPRD
TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
| Date | Jul 20, 2004 (initiated Feb 16, 2004) |
| Status | Terminated |
| Reason | The package inserts contain incorrect control values for the urinary free cortisol extraction procedure. |
| Root cause | Other |
| Action | Field Correction recall by Important Product Information letter dated 2/16/04, sent via e-mail to the Abbott international subsidiaries on the same date for notification of all of their accounts receiving the Cortisol reagents and X Systems Cortisol controls since March 2002. The accounts were informed of the incorrect values for the Cortisol controls, when using the urinary free cortisol extraction procedure, listed in the package inserts of the reagent kits as well as the controls. The letters contained a table listing the incorrect values and the correct values for each of the products, and |
| Quantity | 1,487 kits |
| Distribution | There was no domestic distribution. The product was distributed internationally through Abbott subsidiaries in Canada, United Kingdom, Japan, Singapore, Hong Kong, Korea, Australia, New Zealand, Honduras, Costa Rica, Panama, Dominican Republic, Germany and Pakistan. |
| FDA record | Open on fda.gov |