Z-0064-2008

Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro...

Name: Z-0064-2008 Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro...
Creator: Abbott Diagnostic International, Ltd.
Published: 2007-07-20
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2007-07-20 / Terminated / root cause: labeling and UDI

FDA source

Abbott Diagnostic International, Ltd. began a recall of Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one... on 2007-07-20. The reason FDA records is "Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, is reported for the patient sample". 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-0064-2008
Status: Terminated
Initiated: 2007-07-20
Posted: 2007-11-03
Terminated: 2011-09-09
Recalling firm: Abbott Diagnostic International, Ltd.
Product: Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.
Product code: KXT Enzyme Immunoassay, Digoxin
Reason for recall: Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, is reported for the patient sample.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Abbott Diagnostics International Limited, Ltd., mailed a Product Correction Letter to customers on 7/20/02 advising an additional option(s) has been identified to resolve Error Codes: - Perform one of the two options to resolve these error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay. - Dilute the sample one to one (1 part sample plus 1 part Calibrator A) and repeat analysis. - The final concentration is equal to the reported concentration of the sample multiplied by the dilution factor - The minimum final concentration that may be reported out is 0.6 ng/mL, which corresponds to the sensitivity of the AxSYM Digoxin III assay (0.3 ng/mL) multiplied by the dilution factor (2). OR - Centrifuge the sample at 8,000 to 10,000 RCF for 10 minutes and repeat analysis.
Quantity in commerce: 3,104
Distribution: Worldwide Distribution -- USA including States of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, MT, NV, NJ, NY, NC, OH, OK, OR, PA, SD, SC, TN, TX, UT, VA, VT, WA, WI, WY, HI, Puerto Rico, and countries of Canada, Venezuela, Uruguay, Germany, Hong Kong, South Korea, Australia, and New Zealand
Product codes and lots: Lot # 46181Q100 Exp.Date 08/10/07, Lot # 50267Q100 Exp.Date 12/16/07

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)