Abbott AxSYM System Digoxin III Reagent Pack
FDA device recall Z-1202-2007 · posted 2007-08-29 · Terminated
Recall details
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Reason for recall
- Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KXT
- Quantity affected
- 2,579 kits
- Distribution
- Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand.
- Date initiated
- 2007-03-30
- Date posted
- 2007-08-29
- Date terminated
- 2011-06-10
- Location
- Barceloneta, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXSYM DIGOXIN III (K061249) | Abbott Laboratories | 2006-06-02 |