FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. Intended to be used with the Access Immunoassay System to remove waste from the system.
- Recall number
- Z-0914-2010
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. Intended to be used with the Access Immunoassay System to remove waste from the system.
- Status
- Terminated
- Initiated
- 2008-10-09
- Posted
- 2010-03-02
- Terminated
- 2012-05-04
- Reason
- The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is limited to those UniCel DXI 800, DXI 600, and DxC 880i systems which have a pump identified with one of the new pump manufacturing numbers (Mfg. Nos.) listed ab
- Root cause
- Other
- Action
- Beckman Coulter contacted consignees via "Urgent Product Corrective Action" letter dated October 16, 2008 to inform them of the recall and to arrange a date to service the affected product as soon as possible. For further information, contact Beckman Coulter: (a)In the U.S.A. or Canada, contact Technical Support at 800-854-3633 or online at www.beckman.com/customersupport. (b) Outside the U.S.A. and Canada, contact your technical support representative.
- Quantity
- 107 (US), 7 (OUS)
- Distribution
- Worldwide Distribution -- United States and Canada.
- Lot, serial or model codes
- Pump Part Numbers A62712, A62839, A62840, A62841, and A63124; Instrument Part Numbers: 973100, A30260, and A59102.
- 510(k) numbers
- ["K023764","K060256"]
- 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