Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila
Lot Codes / Batch Numbers
Lot # 46181Q100 Exp.Date 08/10/07, Lot # 50267Q100 Exp.Date 12/16/07
Products Sold
Lot # 46181Q100 Exp.Date 08/10/07, Lot # 50267Q100 Exp.Date 12/16/07
Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila is recalling Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitr due to Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concen. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, WY, PR
Page updated: Jan 10, 2026