CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
Aqure System recalled by Radiometer America
Radiometer America is recalling Aqure System, distributed in Michigan, New York. The recall was initiated on 23 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0899-2017
- FDA event ID
- 75836
- Recalling firm
- Radiometer America, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Nov 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Patient Monitors
Timeline
| 23 Nov 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +29 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage 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 you 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.
Where it was distributed
Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
Questions about this recall
Why was it recalled?
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Which lots are affected?
UDI: (01)05700699335999(10)2.2.0
Where was it sold?
Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Radiometer America
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ABL90 FLEX Analyzer recalled by Radiometer America | Radiometer America | Device Malfunction | 36 states |
| Device | CLASS II | ABL800 FLEX with Crea recalled by Radiometer America | Radiometer America | Other | 31 states |
| Device | CLASS II | ABL800 analyzer recalled by Radiometer America | Radiometer America | Device Malfunction | Nationwide |
| Device | CLASS II | ABL90 FLEX analyzers recalled by Radiometer America | Radiometer America | Device Malfunction | CA |
| Device | CLASS II | ABL800 analyzer with Flexq module recalled by Radiometer America | Radiometer America | Other | Nationwide |
Other Patient Monitors recalls
All 1,014| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | nGenuity Patient Monitor with Capnography recalled | Criticare Technologies | Device Malfunction | Nationwide |
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |