Beckman Coulter Inc ICON 25 hCG Test Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ICON 25 hCG Test Kit
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lot hCG030303
Products Sold
Lot hCG030303
Beckman Coulter Inc is recalling ICON 25 hCG Test Kit due to False negative urine results are being observed at an increasing rate.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False negative urine results are being observed at an increasing rate.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026