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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM Digoxin III Reagent Pack

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  Class 2 Device Recall AxSYM Digoxin III Reagent Pack see related information
Date Initiated by Firm July 20, 2007
Date Posted November 03, 2007
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-0064-2008
Recall Event ID 39416
510(K)Number K061249  
Product Classification Digoxin Enzyme Immunoassay - Product Code KXT
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.
Code Information Lot # 46181Q100 Exp.Date 08/10/07, Lot # 50267Q100 Exp.Date 12/16/07
Recalling Firm/
Manufacturer		 Abbott Diagnostic International, Ltd.
Carr # 2 Km 58.0
Cruce Davila
Barceloneta PR 00617-3009
For Additional Information Contact
787-846-3500
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KXT and Original Applicant = ABBOTT LABORATORIES
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