TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall Z-0723-04 · Posted 2004-07-20
Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeJFT
Date Initiated2004-02-16
Date Terminated2004-07-26
Product Quantity1,487 kits
Reason for Recall
The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.
Firm 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 the users were instructed to use the corrected values as provided in the letter.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.