Cl II Radiometer AQURE System

Company: Radiometer America Inc
Date of Enforcement Report 2/10/2016
Class lI:

PRODUCT

AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Recall Number Z-0748-2016

REASON
The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results..

RECALLING FIRM/MANUFACTURER
Radiometer America Inc, Brea, CA on 12/29/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
375

DISTRIBUTION
Nationwide and Internationally

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.