FDA Medical Device Recalls (openFDA)
Abbott Diagnostic International, Ltd.: Abbott AxSYM System Digoxin III Reagent Pack
- Recall number
- Z-1202-2007
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Product
- Abbott AxSYM System Digoxin III Reagent Pack
- Status
- Terminated
- Initiated
- 2007-03-30
- Posted
- 2007-08-29
- Terminated
- 2011-06-10
- 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.
- Lot, serial or model codes
- Lot # 42740Q100 Exp Date: 05/11/07 Lot # 46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date: 05/11/07
- 510(k) numbers
- ["K061249"]
- PMA numbers
- not on file
- Product code
- KXT
- Firm FEI
- 2623532
- Firm city
- Barceloneta
- Firm state
- PR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28