Z-0278-04

Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and...

Name: Z-0278-04 Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-11-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-11-17 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2; Abbott Laboratories, Diagnostics Division... on 2003-11-17. The reason FDA records is "The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges". 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-0278-04
Status: Terminated
Initiated: 2003-11-17
Posted: 2004-07-20
Terminated: 2004-11-01
Recalling firm: Abbott Medical
Product: Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Product code: LCD Enzyme Immunoassay, Gentamicin
Reason for recall: The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Field Correction recall by undated letter sent on 11/17/03 to all customers receiving the affected lots of reagents. The accounts were informed of the incorrect values for the alternate unit (mol/L) Control Ranges 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 use the correct values listed in the table for the assays. The letters also listed the package insert item numbers for the updated inserts being used in current reagent production.
Quantity in commerce: 9,010 kits
Distribution: Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.
Product codes and lots: Reagent List 9512-60,lots 06313Q100, 01368Q101, 95380Q100, 93579Q100, 90107Q100; and Reagent List 9512-85, lots 06312Q100, 02010Q100, 96606Q100, 95106Q100, 90108Q100 that contain insert item numbers 34-1074/R3 or 69-5120/R2

Product code LCD

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)