FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: ICON DS hCG, an in-vitro diagnostic. Part number 44025.
- Recall number
- Z-0706-03
- Recalling firm
- Beckman Coulter Inc
- Product
- ICON DS hCG, an in-vitro diagnostic. Part number 44025.
- Status
- Terminated
- Initiated
- 2003-02-20
- Posted
- 2003-04-02
- Terminated
- 2003-09-25
- Reason
- Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
- Root cause
- Other
- Action
- Distributors/customers were sent a recall letter dated 2/20/03 instructing them to discontinue use of the product.
- Quantity
- 12,804
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Lot numbers hCG010401, hCG010704, hCG010902
- 510(k) numbers
- ["K993203"]
- 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