Radiometer Medical ApS Akandevej 21 Bronshoj Denmark 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.