Use cautionMedical device recall · FDA · Published March 6, 2020
Radiometer ABL800 FLEX: Power supply issue may delay treatment
Radiometer recalls ABL800 FLEX models 393-800 and 393-801 with UDI (01)05700693938004 due to a power supply defect that could delay critical treatment. Affected units have specific serial numbers.
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
Take action
Contact the company
📍Recalling firmRadiometer Medical ApSAkandevej 21 · Bronshoj, Denmark
“Radiometer ABL800 FLEX: Power supply issue may delay treatment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65708-radiometer-abl800-flex-power-supply-issue-may-delay-treatment. Based on FDA recall #Z-1836-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1836-2020%22&limit=1).
The FDA announced on March 6, 2020, that Radiometer Medical ApS is recalling two ABL800 FLEX analyzers due to a power supply component error. The defect may cause short circuits and treatment delays leading to serious cardiac risks.
How to tell if you have it
ABL800 FLEX model number 393-800
ABL800 FLEX model number 393-801
UDI:(01)05700693938004
Serial Numbers: 902-754R2692N002 and 902-754R2692N001
Sold in California
The hazard
An incorrect component in the power supply may cause a short circuit, resulting in treatment delays. These delays could lead to cyanosis, low blood pressure, cardiac arrhythmias, and severe impairment of cardiac function.
Context
Radiometer Medical ApS has 16 other recalls on record since February 27, 2018. Other recent recalls include Radiometer ABL90 FLEX Analyzers with Windows 10 RWIN10 1.0/1.1 May Freeze During Tests (March 21, 2025) and Radiometer ABL800 FLEX Analyzers: Calibration Solution pH Issue (May 31, 2024). Other recent recalls of similar products include Abiomed Impella RP Flex SmartAssist: Sensor Drift Risk (January 27, 2026), Medline Namic Preceptor Manifold Recall: Particulate Risk in Blood Pressure Transducers (March 24, 2026), and Spacelabs Healthcare Multi-parameter Command Module Model 91496 Recall: Inaccurate Cardiac Output Readings (February 27, 2026).
How to tell if you have this one
Check for model numbers 393-800 or 393-801 on the device. The unique device identifier (UDI) (01)05700693938004 is also associated with these units. Serial numbers 902-754R2692N002 and 902-754R2692N001 are affected.
Brand
Radiometer
Product
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for model numbers 393-800 or 393-801 on the device.
Contact Radiometer
Reach out to Radiometer Medical ApS for further assistance with the recall.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
FDA distribution: “US: in the state of California” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1836-2020 (March 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1836-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.