Radiometer ABL90 Series - Radiometer ABL90 FLEX
Medical device recall Z-1659-2025. Published in FDA’s Enforcement Report on Apr 30, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 30, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 48 states named in where it went
- 6275 analyzers how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
6275 analyzers, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,991 characters
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 092R0227N077 092R0227N078 092R0228N007 092R0228N008 092R0228N030 092R0229N040 092R0229N052 092R0230N029 092R0230N030 092R0230N033 092R0230N037 092R0230N059 092R0230N068 092R0230N069 092R0230N070 092R0231N004 092R0231N007 092R0231N012 092R0231N013 092R0231N015 092R0231N016 092R0231N024 092R0231N029 092R0231N030 092R0231N031 092R0231N032 092R0231N033 092R0231N034 092R0231N035 092R0231N037 092R0231N040 092R0232N054 092R0233N024 092R0233N026 092R0234N006 092R0234N008 092R0234N009 092R0234N010…
FDA’s list runs to 23,219 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
48 states and territories.
Every one of them
- 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
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 21, 2025.
- FDA classified it on Apr 23, 2025.
- FDA’s Enforcement Report published it on Apr 30, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Radiometer Medical ApS, of Bronshoj, Denmark.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 23,219 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.