Recall Z-1202-2007
Abbott Diagnostic International, Ltd. · initiated March 30, 2007
Product
Abbott AxSYM System Digoxin III Reagent Pack
Codes / lots: Lot # 42740Q100 Exp Date: 05/11/07 Lot # 46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date: 05/11/07
Reason for recall
Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1202-2007
- Initiated
- March 30, 2007
- Posted by FDA
- August 29, 2007
- Terminated
- June 10, 2011
- Product code
- KXT – Enzyme Immunoassay, Digoxin
- Quantity
- 2,579 kits
- Distribution
- Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand.
- Recalling firm
- Abbott Diagnostic International, Ltd., Barceloneta, PR