AQURE System recallZ-0899-2017 · Radiometer America Inc · initiated Nov 23, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Radiometer America Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
FDA root cause category: Software design
What the company is doing
Radiomet4er sent a letter dated November 30, 2016, to all affected customers via email with a request for customers to complete a return form. Customers/Users were advised to not use the "more" button to expand patient results when viewing them in the AQURE patient view. Customers/Users Radiometer Representative will contact them to schedule a visit of a remote session. During the visit or remote session the representative will run a script on the AQURE system, which serve to remove the misalighnment possibility. It is noted in the letter to customers that expanding the results by using the More button will not affect the stored results. If customers are not the end-user of the affected product ensure that the notification letter is distributed to the final end-user. If any questions regarding the notification letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1. For questions regarding this recall call 440-871-8900.
Recall details
- Recall number
- Z-0899-2017
- Status
- Terminated
- Initiated by the company
- Nov 23, 2016
- Posted by the FDA
- Dec 22, 2016
- Recalling firm
- Radiometer America Inc
- Quantity
- 7 total (2 in US)
- Product code
- CHL
- FDA submissions
- K130144, K142898, K151856
- Distribution
- Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
Product description
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.
Code information (models, lots, serial numbers)
UDI: (01)05700699335999(10)2.2.0
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AQURE 933-599Radiometer Medical ApS · Medical device data system2 recalls7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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