Recall Z-1202-2007 ยท KXT Enzyme Immunoassay, Digoxin
Abbott Diagnostic International, Ltd.
Abbott AxSYM System Digoxin III Reagent Pack
| Date | Aug 29, 2007 (initiated Mar 30, 2007) |
| Status | Terminated |
| Reason | Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay. |
| Root cause | Other |
| 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. |
| Quantity | 2,579 kits |
| Distribution | Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061249 | AXSYM DIGOXIN III Abbott Laboratories, Jun 2, 2006 |