FDA Device recall Z-2272-2016
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300
- FDA Device
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300 by Beckman Coulter, citing possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2272-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-22 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | PR |
Product
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. Catalog No. UniCel DxC 800 Synchron Clinical Systems UniCel DxC 600 Synchron Clinical Systems UniCel DxC 600i Synchron Access Integrated Clinical Systems UniCel DxC 880i Synchron Access Integrated Clinical Systems UniCel DxC 660i Synchron Access Integrated Clinical Systems Product Labeling Reference No. A93719 For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
Reason
Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
Identifiers
| code_info | Up to and including 6133 |
|---|
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-2272-2016%22
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