FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: SYNCHRON CX5 CE Clinical System Part #: 448700 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine
- Recall number
- Z-0129-2012
- Recalling firm
- Beckman Coulter Inc.
- Product
- SYNCHRON CX5 CE Clinical System Part #: 448700 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine
- Status
- Terminated
- Initiated
- 2010-08-23
- Posted
- 2011-10-27
- Terminated
- 2012-06-28
- Reason
- The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.
- Root cause
- Software design
- Action
- Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 20, 2010 with an attached Fax Back Response Form (via US Postal Service for US Customers) to all customers who purchased the Synchron CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems. The letter provides the customers wtih an explanation of the problem identified and actions to be taken. Customers were instructed to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded the affected product listed above to another laboratory, they were asked to provide a copy of this letter to them. Questions regarding this Product Corrective Action letter, were directed to Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada. Outside the United States and Canada, they were directed to their local Beckman Coulter Representative.
- Quantity
- 1070 systems total in US
- Distribution
- Worldwide Distribution - USA (nationwide) and the country of Canada
- Lot, serial or model codes
- All non-PRO Software Versions
- 510(k) numbers
- ["K926060"]
- 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