TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA device recall Z-0723-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JFT
- Quantity affected
- 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, Hondu
- Date initiated
- 2004-02-16
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-26
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TDX CORTISOL (K854419) | Abbott Laboratories | 1985-11-25 |
| TDX CORTISOL (K852927) | Abbott Laboratories | 1985-08-05 |