Recall record at a glance
| Official record | Z-1582-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Radiometer Medical ApS |
| Report date | May 9, 2018 |
| Recall initiation date | Feb 27, 2018 |
| Quantity | 2 |
| Location | Bronshoj, N/A, Denmark |
Official 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.
Why the product was recalled
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 information
US Nationwide Distribution in the states to Georgia and Wisconsin.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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