FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Access Immunoassay Systems Assay Protocol: Dil-AFP.
- Recall number
- Z-1388-05
- Recalling firm
- Beckman Coulter Inc
- Product
- Access Immunoassay Systems Assay Protocol: Dil-AFP.
- Status
- Terminated
- Initiated
- 2005-07-18
- Posted
- 2005-08-23
- Terminated
- 2012-03-07
- Reason
- Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results.
- Root cause
- Other
- Action
- Letters to customers were sent July 18, 2005. Firm will upgrade software later in the year. Customers are advised to not perform the automated dilution protocol but refer to the method in the directions.
- Quantity
- 311 USA 16 Canada
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- All lot numbers.
- 510(k) numbers
- ["K981354"]
- PMA numbers
- not on file
- Product code
- LOJ
- 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