FDA Device recall Z-0059-2013
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems
- FDA Device
- Class II
- terminated
- Published 2012-10-24
On 2012-10-24 the FDA classified a Class II recall of Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems by Beckman Coulter, citing the recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Ali….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0059-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-06 |
| Published | 2012-10-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
Reason
The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial numbers between 547 and 574 may cause a hardware motion error (ID0x08000501).
Identifiers
| code_info | Serial Numbers: 547-574 (UCTA) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0059-2013%22
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