Z-0723-04

TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL...

Name: Z-0723-04 TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2004-02-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-02-16 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 on 2004-02-16. The reason FDA records is "The package inserts contain incorrect control values for the urinary free cortisol extraction procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0723-04
Status: Terminated
Initiated: 2004-02-16
Posted: 2004-07-20
Terminated: 2004-07-26
Recalling firm: Abbott Medical
Product: TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Product code: JFT Fluorometric, Cortisol
Reason for recall: The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.
Root cause tag: labeling and UDI
FDA 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 the users were instructed to use the corrected values as provided in the letter.
Quantity in commerce: 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.
Product codes and lots: list 9116-65, lots 04111M200, 10239M200, 10060M200, 10060M201

Product code JFT

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)