Reported Aug 3, 2016 · Terminated
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- 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.
- Lot codes and dates
- Up to and including 6133
- Amount recalled
- 3,540 units total (1,067 units in US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
This product could cause temporary or reversible health problems — stop using it.
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