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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