Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila Abbott AxSYM System Digoxin III Reagent Pack Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott AxSYM System Digoxin III Reagent Pack
Brand
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot # 42740Q100 Exp Date: 05/11/07 Lot # 46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date: 05/11/07
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila is recalling Abbott AxSYM System Digoxin III Reagent Pack due to Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.
Recommended Action
Per FDA guidance
On Abbott letterhead dated March 30, 2007 - The instructions are to provide a copy of the accompanying Product Correction Letter to the laboratory manager/supervisor responsible for AxSYM Digoxin II or AxSYM Digoxin III testing. The laboratory manager/supervisor should complete the information on the letter acknowledging receipt of the product Correction Letter and Fax the Customer Reply Form, prior April 12, 2007 to Fax number 1-800-777-0051.
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
PR
Page updated: Jan 10, 2026