AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
FDA Recall #Z-0748-2016 — Class II — December 29, 2015
Product Description
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Reason for Recall
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
Radiometer America Inc — Brea, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
375
Distribution
Worldwide Distribution-US (nationwide) including the states of PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.
Code Information
Model Number: 933-599 Version 1.8.3
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated