Class 2 Device Recall Radiometer, ABL 80, ABL90, ABL 800 FLEX Blood Gas analyzers with AQURE Software version 2.2.0

• Date Initiated by Firm: November 23, 2016
• Date Posted: December 22, 2016
• Recall Status: Terminated on February 07, 2017
• Recall Number: Z-0899-2017
• Recall Event ID: 75836
• 510(K)Number: K151856 K130144 K142898
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: 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: UDI: (01)05700699335999(10)2.2.0
• Recalling Firm/ Manufacturer: Radiometer America Inc; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Radiometer America Technical Support; 440-871-8900
• Manufacturer Reason for Recall: Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 7 total (2 in US)
• Distribution: Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CHL and Original Applicant = RADIOMETER MEDICAL APS; 510(K)s with Product Code = CHL and Original Applicant = Radiometer Medical Aps.; 510(K)s with Product Code = CHL and Original Applicant = SENDX MEDICAL INC.