FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i). Intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid.
- Recall number
- Z-0863-2010
- Recalling firm
- Beckman Coulter Inc.
- Product
- Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i). Intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid.
- Status
- Terminated
- Initiated
- 2010-01-04
- Posted
- 2010-03-04
- Terminated
- 2012-04-17
- Reason
- Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results.
- Root cause
- Device Design
- Action
- An Urgent: Product Corrective Action letter dated January 4, 2010, was mailed to customers advising of erroneous sodium results derived from build up of protein, bacteria and additives in the ISE flow cell. The letter discussed the impact and actions to be taken along with some additional recommendations. Customers are advised to follow the new maintenance instructions included with the letter. The information in the letter should be shared with laboratory staff and the notification should be retained as part of the Quality System documentation. A copy of the letter should be provided to any other laboratory that affected product was forwarded to. The enclosed response form should be completed and returned. Questions should be directed to the Customer Support Center at 1-800-854-3633.
- Quantity
- 2630
- Distribution
- Worldwide Distribution -- USA and Canada.
- Lot, serial or model codes
- All serial numbers. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i); and A64935 (UniCel DxC 860i).
- 510(k) numbers
- ["K042291","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