Medical DevicesNationwide
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 HCG030732
Products Sold
Lot HCG030732
Beckman Coulter Inc is recalling ICON 25 hCG test kit. due to Test can exhibit false negative results.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: distribution information.
Reason for Recall
As stated by FDA
Test can exhibit false negative results.
Recommended Action
Per FDA guidance
Customer letter was sent 12/22/03 via US Mail. It instructs users to discontinue use of product for replacement.
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