FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Access Immunoasay Systems Digoxin Reagent
- Recall number
- Z-0576-05
- Recalling firm
- Beckman Coulter Inc
- Product
- Access Immunoasay Systems Digoxin Reagent
- Status
- Terminated
- Initiated
- 2005-02-23
- Posted
- 2005-03-08
- Terminated
- 2005-09-02
- Reason
- Variability in results on Patient and QC results of 20-25%, high and low.
- Root cause
- Other
- Action
- Letters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.
- Quantity
- 4352 domestically.
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Lots 323171; 416110; 417703; 419534
- 510(k) numbers
- ["K925802"]
- PMA numbers
- not on file
- Product code
- KXT
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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