Abbott AxSYM System Digoxin III Reagent Pack
This recall has been terminated (originally issued August 29, 2007).
- Recall Initiated
- March 30, 2007
- Posted
- August 29, 2007
- Terminated
- June 10, 2011
- Recall Number
- Z-1202-2007
- Quantity
- 2,579 kits
- Firm Location
- Barceloneta, PR
- Official Source
- View on FDA website ↗
Reason for Recall
Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.
Distribution
Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand.
Lot / Code Info
Lot # 42740Q100 Exp Date: 05/11/07 Lot # 46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date: 05/11/07
Root 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.