FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
- Recall number
- Z-0046-2018
- Recalling firm
- Beckman Coulter Inc.
- Product
- Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
- Status
- Terminated
- Initiated
- 2017-08-03
- Posted
- not on file
- Terminated
- 2023-09-27
- Reason
- Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process, which should not occur. This issue and associated complaint were discovered and filed internally.
- Root cause
- Software design
- Action
- BEC will initiate a SW update- to fix the SW defect. This will be executed via MOD (field modification) performed by Field Service.
- Quantity
- 27 units
- Distribution
- China France Italy Kuwait Spain Turkey United States
- Lot, serial or model codes
- Software version PLC V26R10
- 510(k) numbers
- ["K110413"]
- PMA numbers
- not on file
- Product code
- JJE
- 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