Recalls / —

—#30327

Product

ICON 25 hCG Test Kit

FDA product code

JHI — Visual, Pregnancy Hcg, Prescription Use

Device class

Class 2

Medical specialty

Clinical Chemistry

Affected lot / code info

Lot hCG030303

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern

Nationwide and Canada (limited).

Timeline

Recall initiated

2003-10-31

Posted by FDA

2004-07-20

Terminated

2004-05-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #30327. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.