Z-1202-2007

Abbott AxSYM System Digoxin III Reagent Pack

Name: Z-1202-2007 Abbott AxSYM System Digoxin III Reagent Pack
Creator: Abbott Diagnostic International, Ltd.
Published: 2007-03-30
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2007-03-30 / Terminated

FDA source

Abbott Diagnostic International, Ltd. began a recall of Abbott AxSYM System Digoxin III Reagent Pack on 2007-03-30. The reason FDA records is "Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1202-2007
Status: Terminated
Initiated: 2007-03-30
Posted: 2007-08-29
Terminated: 2011-06-10
Recalling firm: Abbott Diagnostic International, Ltd.
Product: Abbott AxSYM System Digoxin III Reagent Pack
Product code: KXT Enzyme Immunoassay, Digoxin
Reason for recall: Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.
FDA root cause: Other
Action: On Abbott letterhead dated March 30, 2007 - The instructions are to provide a copy of the accompanying Product Correction Letter to the laboratory manager/supervisor responsible for AxSYM Digoxin II or AxSYM Digoxin III testing. The laboratory manager/supervisor should complete the information on the letter acknowledging receipt of the product Correction Letter and Fax the Customer Reply Form, prior April 12, 2007 to Fax number 1-800-777-0051.
Quantity in commerce: 2,579 kits
Distribution: Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand.
Product codes and lots: Lot # 42740Q100 Exp Date: 05/11/07 Lot # 46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date: 05/11/07

Product code KXT

K061249Class IIAxsym Digoxin IIIAbbott Laboratories / cleared 2006-06-02

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)