AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analy
FDA device recall Z-1582-2018 · posted 2018-03-14 · Terminated
Recall details
- Recalling firm
- Radiometer Medical ApS
- 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.
- Action taken
- Radiometer Medical sent a Notification letter dated February 27, 2018 to customers. The letter identified the affected product, problem and actions to be taken For questions contact your Radiometer representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 2
- Distribution
- US Nationwide Distribution in the states to Georgia and Wisconsin.
- Date initiated
- 2018-02-27
- Date posted
- 2018-03-14
- Date terminated
- 2019-03-20
- Location
- Bronshoj, Denmark
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL80 FLEX CO-OX with AQURE connectivity (K151856) | Sendx Medical, Inc. | 2015-08-06 |
| ABL800 FLEX with AQURE connectivity (K142898) | Radiometer Medical Aps | 2015-06-17 |
| ABL90 FLEX (K130144) | Radiometer Medical Aps | 2013-07-31 |