FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: ICON 25 hCG Test Kit
- Recall number
- Z-0163-04
- Recalling firm
- Beckman Coulter Inc
- Product
- ICON 25 hCG Test Kit
- Status
- Terminated
- Initiated
- 2003-10-31
- Posted
- 2004-07-20
- Terminated
- 2004-05-17
- Reason
- False negative urine results are being observed at an increasing rate.
- Root cause
- Other
- Action
- 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.
- Quantity
- 9040 kits
- Distribution
- Nationwide and Canada (limited).
- Lot, serial or model codes
- Lot hCG030303
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JHI
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28