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Terminated

ICON 25 hCG test kit.

FDA Recall Z-0374-04 · Posted 2004-01-29

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJHI
Date Initiated2003-12-22
Date Terminated2004-05-24

Reason for Recall

Test can exhibit false negative results.

Firm Action

Customer letter was sent 12/22/03 via US Mail. It instructs users to discontinue use of product for replacement.

Root Cause

Other

Official Source

View FDA Recall →

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

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