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
Summary
The FDA issued a Class II for AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQ by Radiometer Medical ApS. Reason: Due to potential software issue that may result in patient mix-up information..
Details
Source
Device Recall
External ID
Z-1394-2023
Action Date
2023-04-26
Status
Ongoing
Category
device
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.
Lot/Code Info: Model Number: 933-599 UDI-DI Code: 05700699335999 Software Versions: 2.5.2 and above (Versions 2.5.2, 2.5.3, 2.5.4, 2.60, and 2.6.1)
Quantity Affected: 1,806 systems
Reason for Recall
Due to potential software issue that may result in patient mix-up information.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-08
Company
Bronshoj, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Radiometer Medical ApS has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Radiometer Medical ApS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Radiometer Medical ApS have FDA actions?
Radiometer Medical ApS has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1394-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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