FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: ACCESS Estradiol Reagent Test System
- Recall number
- Z-0872-03
- Recalling firm
- Beckman Coulter Inc
- Product
- ACCESS Estradiol Reagent Test System
- Status
- Terminated
- Initiated
- 2003-05-08
- Posted
- 2003-05-29
- Terminated
- 2003-10-14
- Reason
- Short volume, resulting possibility of falsely elevated results.
- Root cause
- Other
- Action
- Consignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit.
- Quantity
- 1593 kits
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Lot number 215173
- 510(k) numbers
- ["K973743"]
- PMA numbers
- not on file
- Product code
- CHP
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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