Z-1582-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- February 27, 2018
- Termination Date
- March 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets the user send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
Reason for Recall
There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
Distribution Pattern
US Nationwide Distribution in the states to Georgia and Wisconsin.
Code Information
Version 2.3.0 and 2.3.1