FDA Device recall Z-0310-2018
UniCel DxC 600i SYNCHRON Access Clinical Systems
- FDA Device
- Class III
- terminated
- Published 2018-01-10
On 2018-01-10 the FDA classified a Class III recall of UniCel DxC 600i SYNCHRON Access Clinical Systems by Beckman Coulter, citing potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0310-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-11-06 |
| Published | 2018-01-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | GA |
Product
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reason
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Identifiers
| code_info | Serial/Lot Numbers: 801060 and 801061 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0310-2018%22
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