ICON 25 hCG test kit.
FDA device recall Z-0374-04 · posted 2004-01-29 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Test can exhibit false negative results.
- Action taken
- Customer letter was sent 12/22/03 via US Mail. It instructs users to discontinue use of product for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- JHI
- Date initiated
- 2003-12-22
- Date posted
- 2004-01-29
- Date terminated
- 2004-05-24
- Location
- Brea, CA
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