| Class 2 Device Recall AxSYM Digoxin III Reagent Pack | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KXT
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