FDA Medical devices recall · April 30, 2025

Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090… recall

Read the official FDA notice ↗

Product

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.

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Model Number: 393-090 UDI-DI: 05700693930909 Model Number: 393-092 UDI-DI: 05700693930923 Serial Numbers: 090R0643N002 090R0749N001 090R0757N002 090R0757N004 090R0861N018 090R0874N009 090R0874N011 090R0874N012 090R0892N012 090R0897N023 090R0902N025 090R0943N010 090R0965N003 090R0965N007 090R0965N009 092R0150N001 092R0173N047 092R0173N049 092R0177N055 092R0180N011 092R0180N014 092R0180N025 092R0180N027 092R0185N022 092R0185N024 092R0185N025 092R0185N026 092R0187N016 092R0187N019 092R0187N021 092R0187N026 092R0187N027 092R0188N022 092R0188N024 092R0188N025 092R0188N026 092R0188N027 092R0188N028 092R0188N029 092R0188N033 092R0191N002 092R0195N034 092R0197N026 092R0197N028 092R0197N031 092R0198N005 092R0198N006 092R0198N008 092R0198N009 092R0198N014 092R0198N019 092R0198N027 092R0198N031 092R0200N041 092R0201N001 092R0201N003 092R0201N004 092R0201N006 092R0201N008 092R0204N035 092R0204N036 092R0214N011 092R0214N012 092R0214N013 092R0216N003 092R0216N004 092R0216N005 092R0216N006 092R0216N007 092R0216N016 092R0216N017 092R0216N020 092R0216N021 092R0218N014 092R0218N047 092R0218N048 092R0218N050 092R0221N011 092R0223N008 092R0223N011 092R0223N024 092R0223N026 092R0223N048 092R0223N050 092R0225N032 092R0225N039 092R0225N049 092R0225N050 092R0225N051 092R0225N052 092R0225N053 092R0225N054 092R0226N001 092R0226N002 092R0226N003 092R0226N015 092R0226N016 092R0226N018 092R0226N019 092R0227N047 092R0227N050 092R0227N051 092R0227N053 092R0227N054 092R0227N055 092R0227N056 092R0227N062 092

Distribution

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

States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Pennsylvania Puerto Rico Rhode Island South Carolina Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1659-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.