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Terminated

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.

FDA Recall Z-0064-2008 · Posted 2007-11-03

Recalling FirmAbbott Diagnostic International, Ltd.
Recall StatusTerminated
Product CodeKXT
Date Initiated2007-07-20
Date Terminated2011-09-09
Product Quantity3,104

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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061249AXSYM DIGOXIN IIIAbbott Laboratories · 2006-06-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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