Z-0508-04

TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

Name: Z-0508-04 TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-12-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-12-05 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 on 2003-12-05. The reason FDA records is "The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table". 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-0508-04
Status: Terminated
Initiated: 2003-12-05
Posted: 2004-02-04
Terminated: 2005-04-25
Recalling firm: Abbott Medical
Product: TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Product code: DIC--
Reason for recall: The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Field Correction recall by Important Product Information letter dated 12/5/03, sent via Federal Express Priority on the same date to all customers receiving the affected reagents. The accounts were informed of the incorrect values for the Specific Performance Characteristics listed in the package inserts of the reagent kits. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to replace their product inserts with the enclosed revised package inserts for all product specific reagent kits in their laboratory.
Quantity in commerce: 3,222 kits
Distribution: Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Colombia, Chile, Argentina, Brazil, Puerto Rico, San Salvador, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand, Honduras, Costa Rica, Bahamas, Panama, Dominican Republic and China.
Product codes and lots: All lots with insert version 69-5787/R4. The corrected insert is version 34-2778/R5.

Product code DIC--

K871645Class IITdxr Rea(tm) EthanolAbbott Laboratories / cleared 1987-06-11

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)