Recalling Firm / Manufacturer

Abbott Diagnostic International, Ltd.

Product

Abbott AxSYM System Digoxin III Reagent Pack

Code Information

Lot # 42740Q100 Exp Date: 05/11/07 Lot # 46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date: 05/11/07

Reason of Recall

Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.

Date Recall Initiated

March 30, 2007

Action

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. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.