Beckman Coulter Inc Access Immunoassay Systems Assay Protocol: Dil-AFP. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Access Immunoassay Systems Assay Protocol: Dil-AFP.
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
All lot numbers.
Products Sold
All lot numbers.
Beckman Coulter Inc is recalling Access Immunoassay Systems Assay Protocol: Dil-AFP. due to 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 e. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026