Class 2 Device Recall AQURE basic sytem

• Date Initiated by Firm: August 08, 2019
• Create Date: January 24, 2020
• Recall Status: Terminated on June 06, 2022
• Recall Number: Z-0864-2020
• Recall Event ID: 84496
• Product Classification: Medical device data system - Product Code OUG
• Product: AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
• Code Information: Software version 2.3.5 and below
• FEI Number: 3002807968
• Recalling Firm/ Manufacturer: Radiometer Medical ApS; Akandevej 21; Bronshoj Denmark
• Manufacturer Reason for Recall: The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.
• FDA Determined Cause: Software design
• Action: On 07/15/2019, the firm, Radiometer America, Inc., sent an "Urgent: Medical Device Correction" to customers via FedEx with tracking and email to inform them that the firm has become aware that there is a potential problem related to its system that may result in patient mix-up when connected to some third-party devices. This recall affects all system below version 2.3.5. On September 24th, the firm sent a updated letter via email which updated that only 7 third party devices could be potentially affected (Originally 10 third party devices). The firm is instructing customers to: If the customer's affected system is connected to a third-party device, the Recalling Firm is requesting the customer to inform operators to cease performing queries as described in the scenario above until the affected system has been corrected by the Recalling Firm's representative. Additionally, the firm is asking that the customer please complete the Recall Response Form (last page) and return it to the fax number (714-582-0806) or email address provided (RECALL@READIOMETERAMERICA.COM). For any additional questions, customers are instructed to contact their Recalling Firms representative; or 440-925-34875 or email: jgibbons@radioamerica.com.
• Quantity in Commerce: 947
• Distribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; and countries of:  Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Italy, Japan (Tokyo-not a country but it was listed), Netherlands, Norway, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
• 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.