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RecallWatchMedical Device Safety
Class IIOngoingZ-1659-2025

Radiometer Medical ApS recalls Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL9…

Radiometer Medical ApSBronshoj, DenmarkReported Apr 30, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings
    UDI-DI 05700693930909Model Number
    400 affected lots
    090R0643N002090R0749N001090R0757N002090R0757N004090R0861N018090R0874N009090R0874N011090R0874N012
    +392 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

What the firm is doing

On 03/21/2025, the firm sent via email and FedEx an "Urgent: Medical Device Recall" Letter informing customers that, Radiometer has become aware of a potential risk with ABL90 FLEX and ABL90 FLEX PLUS analyzers when operating with Radiometer Windows 10 versions (RWIN10 1.0 and 1.1). Specifically, the analyzer software may unexpectedly "freeze" and restart during a sample measurement, causing the analyzer to cease operation during the startup period. Customers are instructed to: 1. Do not use the affected systems without having an alternative solution readily available. Alternative solutions could include using an additional analyzer or sending the sample to a central laboratory. This also involves ensuring that there is enough patient sample for a second measurement, in case the sample is lost due to the analyzer restarting. Additionally, we ask that you please post a copy of this letter on or near the device(s) until such time that the software has been upgraded. Radiometer will contact customers to schedule the upgrade to analyzers to the available software RWIN10 1.2 or greater. For questions, contact Radiometer at 1-800-736-0600 option 1, Monday - Friday 9 AM to 7 PM (EST).

DistributionShow details

U.S.: AL, AR, AZ, BM CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Canada, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Dominican Republic, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Iran, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe, Australia, New Zealand, New Caledonia, Tokelau, Austria, Belgium, Netherlands, China, Croatia, Czech Republic, Slovakia, Denmark, Iceland, Finland, Estonia, France, Germany, Hong Kong, Hungary, India, Brunei, Italy, Japan, Kazakhstan, Malaysia, Mexico, Norway, Poland, Russia, Singapore, South Africa, Cameroon, Ivory Coast, Malawi, South Korea, Spain, Portugal, Sweden, Switzerland, Turkey, United Kingdom, Ireland

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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