Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Access Immunoassay Systems Assay Protocol: Dil-AFP.

FDA Recall Z-1388-05 · Posted 2005-08-23

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeLOJ
Date Initiated2005-07-18
Date Terminated2012-03-07
Product Quantity311 USA 16 Canada

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211Beckman Instruments, Inc. · 1998-05-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑