Z-1229-04

TDx/TDxFLx Opiates Reagent, Product list number: 9673-60

Name: Z-1229-04 TDx/TDxFLx Opiates Reagent, Product list number: 9673-60
Creator: Abbott Health Products, Inc.
Published: 2004-05-28
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2004-05-28 / Terminated / root cause: labeling and UDI

FDA source

Abbott Health Products, Inc. began a recall of TDx/TDxFLx Opiates Reagent, Product list number: 9673-60 on 2004-05-28. The reason FDA records is "Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the TDx/TDxFLx Opiates Reagent package insert (commodity number...". 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-1229-04
Status: Terminated
Initiated: 2004-05-28
Posted: 2004-07-28
Terminated: 2004-09-10
Recalling firm: Abbott Diagnostic International, Ltd.
Product: TDx/TDxFLx Opiates Reagent, Product list number: 9673-60
Product code: DJG Enzyme Immunoassay, Opiates
Reason for recall: Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.
Quantity in commerce: 941 kits
Distribution: Distribution was to hospitals/laboratories
Product codes and lots: Lot/Unit numbers Exp. date 10750Q100 9/22/04 09650Q100 9/15/04

Product code DJG

K874485Class IIRevised Labeling for OpiatesAbbott Laboratories / cleared 1987-11-23

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)