FDA Device recall Z-2247-2016
The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer)
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer) by Beckman Coulter, citing beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2247-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-27 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | PR |
Product
The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.
Reason
Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.
Identifiers
| code_info | All |
|---|
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-2247-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.