Aqure Ref 933-599 recallZ-1394-2023 · Radiometer Medical ApS · initiated Mar 8, 2023

Why it was recalled

Due to potential software issue that may result in patient mix-up information.

FDA root cause category: Software design

What the company is doing

On 03/08/2023, the firm sent an "Urgent: Medical Device Recall" letter via email and FedEx to customers informing them that there is a potential software issue that may result in patient information mix-up when connected to the LumiraDx device. This may potentially result in a patient with critically or life-threatening elevated levels of D-dimer or NT-pro-BNP being diagnosed with levels within the normal range. Customers are instructed to perform: 1) With immediate effect, cease using the LumiraDx devices if connected with an AQURE system with the affected software versions: 2.5.2, 2.5.3, 2.5.4 2.6.0 2.6.1 2) Within two weeks of receipt of this letter, complete and email a copy of the Recall Response Form and return it to a Radiometer Representative. A Radiometer Representative will contact and schedule a visit or remote session to: " If you use LumiraDx devices connected with AQURE, your AQURE system must be upgraded. Your local Radiometer representative will contact you when a solution is available. " If you do not use LumiraDx devices, your Radiometer representative will contact you and remove the LumiraDx driver from the AQURE system, hence preventing the usage of LumiraDx devices in context with your current AQURE system(s). For questions, contact Radiometer at 1-800-736-0600, Monday - Friday 9 am to 7 pm (EST).

Recall details

Recall number

Z-1394-2023

Status

Open, Classified

Initiated by the company

Mar 8, 2023

Posted by the FDA

Apr 17, 2023

Recalling firm

Radiometer Medical ApS

Quantity

1,806 systems

Product code

OUG

Distribution

Worldwide - U.S. Nationwide including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.

Product description

AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• AQURE 933-599

  Radiometer Medical ApS · Medical device data system
  2 recalls7 reports