FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
- Recall number
- Z-2386-2008
- Recalling firm
- Beckman Coulter Inc
- Product
- Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
- Status
- Terminated
- Initiated
- 2008-04-03
- Posted
- 2008-09-21
- Terminated
- 2011-11-29
- Reason
- The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision.
- Root cause
- Nonconforming Material/Component
- Action
- A Product Corrective Action (PCA) letter with attached Fax-Back Customer Response form was mailed on April 16, 2008 via US Postal mail to all affected customers with Access and Access 2 Immunoassay Systems, Synchron LXi 725 Systems and UniCel DxC 600i Systems. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump Mfg. No. 01-00772205 with a SN higher than 2234980. A toll free Customer Technical Support telephone was included in the letter. After further investigation by the firm, an Updated PCA letter with attached Fax-Back Customer Response form was mailed on June 30, 2008 via US Postal mail to include all customers with the following products: UniCel Dxl 800 and DxC 880i Systems with pump manufacturing number (Mfg.) of 01-010341-1 and serial number (SN) 22454201 and above, and UniCel Dxl 600 Systems with a pump Mfg. No. A24468 and SN of 22965501. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump SN referenced. If you have questions, contact Customer Technical Support at 1-800-854-3633.
- Quantity
- 694 Worldwide; 656 in US & 38 in Canada total for all products
- Distribution
- Nationwide, and in Canada
- Lot, serial or model codes
- Unicel DxC 600i with Peristaltic Pumps with Serial Numbers above 22349820 ; Unicel Dxl 600 Peristaltic Pumps with Serial Numbers of 22965501 and above
- 510(k) numbers
- ["K060256"]
- PMA numbers
- not on file
- Product code
- CFR
- 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