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

Coulter Clone B6-FITC Reagent

FDA Recall Z-1071-03 · Posted 2003-07-30

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Date Initiated2003-04-28
Date Terminated2004-04-20
Product Quantity122

Reason for Recall

Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results. It was determined that choice of anticoagulant may have an effect on results for this reagent. The CD23 clone has shown a diminished expression on B-Cell populations when drawn on EDTA tubes, which may lead to inaccurate interpretation of phenotype results.

Firm Action

Customer letters will be sent to all known purchasers on or about 4/28/2003, also existing inventory will be reworked to include a letter describing performance issues when collection occurs using EDTA.

Root Cause

Other

Distribution Pattern

Nationwide and to Canada

Official Source

View FDA Recall →

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

↑