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

ICON 25 hCG Test Kit

FDA Recall Z-0163-04 · Posted 2004-07-20

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJHI
Date Initiated2003-10-31
Date Terminated2004-05-17
Product Quantity9040 kits

Reason for Recall

False negative urine results are being observed at an increasing rate.

Firm Action

Firm sent letter to customers on 31 OCT 03 expressing not to use kits and that another lot will be substituted. Destruction of recalled lot is requested.

Root Cause

Other

Distribution Pattern

Nationwide and Canada (limited).

Official Source

View FDA Recall →

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

↑