—#40748

Product

Access Immunoassay Systems Assay Protocol: Dil-AFP.

FDA product code: LOJ — Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K981354
Affected lot / code info: All lot numbers.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2005-07-18
Posted by FDA: 2005-08-23
Terminated: 2012-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.