TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- February 16, 2004
- Posted
- July 20, 2004
- Terminated
- July 26, 2004
- Recall Number
- Z-0723-04
- Quantity
- 1,487 kits
- Firm Location
- Abbott Park, IL
Reason for Recall
The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.
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.
Lot / Code Info
list 9116-65, lots 04111M200, 10239M200, 10060M200, 10060M201
Root Cause
Other
Action Taken
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.