ICON 25 hCG Test Kit
FDA device recall Z-0163-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- False negative urine results are being observed at an increasing rate.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 9040 kits
- Distribution
- Nationwide and Canada (limited).
- Date initiated
- 2003-10-31
- Date posted
- 2004-07-20
- Date terminated
- 2004-05-17
- Location
- Brea, CA
Monitor recalls programmatically
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