Lower riskMedical device recall · FDA · Published November 21, 2019
Radiometer ABL90 FLEX Analyzers May Give Wrong Blood Test Results
Radiometer recalls ABL90 FLEX blood analyzers and spare hemolyzer units due to potential measurement errors in blood tests. Affected units may provide inaccurate results for certain blood measurements.
The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.
Take action
Contact the company
📍Recalling firmRadiometer Medical ApSAkandevej 21 · Bronshoj, Denmark
“Radiometer ABL90 FLEX Analyzers May Give Wrong Blood Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66458-radiometer-abl90-flex-analyzers-may-give-wrong-blood-test-results. Based on FDA recall #Z-2139-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2139-2020%22&limit=1).
Radiometer Medical ApS recalled ABL90 FLEX analyzers and spare part hemolyzer units on Nov. 21, 2019, due to measurement errors from faulty cuvettes, the FDA said. Owners should contact Radiometer for a remedy.
How to tell if you have it
Brand: Radiometer
Product: ABL90 FLEX, model no. 393-090; R0659 - R0977
Product: Spare Part Hemolyzer Units (902-980): R0526 - R0941
Units affected: 1233
The hazard
The analyzers fail on S7950 QC measurements because hemolyzer cuvettes allow light shunting, leading to perturbed absorbance spectra and measurement errors. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Radiometer Medical ApS has had 16 other recalls since Feb. 27, 2018. Other recent recalls of similar products 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 Cepheid Xpert BCR-ABL Ultra Test Kits May Give Inaccurate Results (Oct. 30, 2025), Siemens Atellica CH A1c_E Hemoglobin Test May Give Low Results (Feb. 23, 2026), and GEM Premier 5000/7000 Blood Analyzers Risk Patient ID Errors with Bar Code Readers (May 8, 2026).
How to tell if you have this one
Check for model number 393-090 on the ABL90 FLEX analyzers and spare part model 902-980. These units were sold between R0526 and R0941 or R0659 and R0977.
Brand
Radiometer
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide. Also distributed OUS.
Recall number
Product, codes & lots
Quantity
Z-2138-2020
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.; ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195; and Spare Part Hemolyzer Units (902-980): R0526 - R0941; Model Number 393-092.
544
Z-2139-2020
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.; ABL90 FLEX Model no. 393-090: R0659 - R0977 and Spare Part Hemolyzer Units (902-980): R0526 - R0941
1233 units
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for model number 393-090 on the ABL90 FLEX analyzers or model 902-980 on spare hemolyzer units.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide. Also distributed OUS.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2139-2020 (November 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2139-2020 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.