ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: “ In Vitro testing…
Medical device recall Z-2426-2024. Published in FDA’s Enforcement Report on Jul 31, 2024.
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 Jul 31, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 44 states named
- 27,127 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?
Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: “ In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) “ In vitro testing of samples of expired air for the parameters pO2 and pCO2 “ In vitro testing of pleura samples for the pH parameter.
27,127 analyzers, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Numbers: 393-800 and 393-801 Part Numbers/Serial Numbers/UDI(-DI) codes: ABL825 754R0100N003 754R0100N003 ABL825 754R0241N010 754R0241N010 ABL825 754R0334N006 754R0334N006 ABL825 754R0417N008 754R0417N008 ABL825 754R0449N004…
Every code shown here, 1,980 characters
Model Numbers: 393-800 and 393-801 Part Numbers/Serial Numbers/UDI(-DI) codes: ABL825 754R0100N003 754R0100N003 ABL825 754R0241N010 754R0241N010 ABL825 754R0334N006 754R0334N006 ABL825 754R0417N008 754R0417N008 ABL825 754R0449N004 754R0449N004 ABL825 754R0487N004 754R0487N004 ABL837 754R0631N006 754R0631N006 ABL825 754R0755N003 754R0755N003 ABL825 754R0757N007 754R0757N007 ABL825 754R0884N007 754R0884N007 ABL825 754R0917N002 754R0917N002 ABL825 754R0918N007 754R0918N007 ABL810 754R0941N008 754R0941N008 ABL827 754R1001N004 (01)05700693938004(10)754R1001N004 ABL805 754R1028N005 754R1028N005 ABL825 754R1105N005 754R1105N005 ABL825 754R1157N006 754R1157N006 ABL825 754R1204N006 754R1204N006 ABL805 754R1209N005 754R1209N005 ABL825 754R1220N003 754R1220N003 ABL805 754R1222N005 754R1222N005 ABL805 754R1222N006 754R1222N006 ABL825 754R1222N009 754R1222N009 ABL825 754R1223N008 754R1223N008 ABL805 754R1226N007 754R1226N007 ABL825 754R1234N003 754R1234N003 ABL825 754R1238N009 754R1238N009 ABL825 754R1238N011 754R1238N011 ABL825 754R1239N007 754R1239N007 ABL825 754R1239N009 754R1239N009 ABL825 754R1239N010 754R1239N010 ABL820 754R1240N011 754R1240N011 ABL825 754R1261N006 754R1261N006 ABL825 754R1262N007 754R1262N007 ABL825 754R1266N006 754R1266N006 ABL825 754R1267N003 754R1267N003 ABL805 754R1291N003 754R1291N003 ABL835 754R1371N011 754R1371N011 ABL835 754R1377N002 754R1377N002 ABL827 754R1404N002 (01)05700693938004(10)754R1404N002 ABL825 754R1427N003 754R1427N003 ABL805 754R1427N007 754R1427N007 ABL805 754R1427N008 754R1427N008 ABL825 754R1428N001 754R1428N001 ABL825 754R1462N005 (01)05700693938004(10)754R1462N005 ABL825 754R1466N007 (01)05700693938004(10)754R1466N007 ABL837 754R1469N002 (01)05700693938004(10)754R1469N002 ABL825 754R1494N004 (01)05700693938004(10)754R1494N004 ABL805 754R1644N003 (01)05700693938004(10)754R1644N003 ABL825 754R1664N005 (01)05700693938004(10)754R1664N005 ABL825 754R1664N007 (01)05700693938004(10)754R1664N007 ABL827 754R1669N006…
FDA’s list runs to 67,873 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.
Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of 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
44 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- 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
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 May 31, 2024.
- FDA classified it on Jul 24, 2024.
- FDA’s Enforcement Report published it on Jul 31, 2024.
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 67,873 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
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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.