Recall Z-2247-2016— Beckman Coulter Inc.

Name: FDA recall Z-2247-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-27

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2016-06-27, terminated 2017-08-25. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-27
Terminated: 2017-08-25
Firm location: Brea, CA, United States

Product description

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 for recall

Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.

Data sourced from openFDA. This site is unofficial and independent of the FDA.