Z-1388-05

Access Immunoassay Systems Assay Protocol: Dil-AFP

Name: Z-1388-05 Access Immunoassay Systems Assay Protocol: Dil-AFP
Creator: Beckman Coulter Inc
Published: 2005-07-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-07-18 / Terminated

FDA source

Beckman Coulter Inc began a recall of Access Immunoassay Systems Assay Protocol: Dil-AFP on 2005-07-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1388-05
Status: Terminated
Initiated: 2005-07-18
Posted: 2005-08-23
Terminated: 2012-03-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems Assay Protocol: Dil-AFP.
Product code: LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Reason for recall: 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.
FDA 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 in commerce: 311 USA 16 Canada
Distribution: Nationwide and Canada
Product codes and lots: All lot numbers.

Product code LOJ

K981354Class IIAccess Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. / cleared 1998-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)