FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Access Progesterone Assay, Part number 33550.
- Recall number
- Z-0494-03
- Recalling firm
- Beckman Coulter Inc
- Product
- Access Progesterone Assay, Part number 33550.
- Status
- Terminated
- Initiated
- 2002-12-06
- Posted
- 2003-01-30
- Terminated
- 2003-07-26
- Reason
- Primary tube sampling issue may cause false low results.
- Root cause
- Other
- Action
- Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem.
- Quantity
- 6,655
- Distribution
- USA and Canada.
- Lot, serial or model codes
- All Lots.
- 510(k) numbers
- ["K955769"]
- PMA numbers
- not on file
- Product code
- JLS
- 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