Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published August 18, 2026

Radiometer ABL90 FLEX Analyzer May Give Inaccurate Test Results

Radiometer recalls ABL90 FLEX analyzers with software versions 3.6 or lower that may produce inaccurate blood test results. Affected units were sold nationwide in the US from 2026.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0190-2027Medical deviceRadiometer ›
✎ GovInfoNow plain-language explainer

Radiometer is recalling ABL90 FLEX and ABL90 FLEX PLUS blood analyzers that may give inaccurate test results. This affects lab tests for blood components like hemoglobin and bilirubin when using older software versions. Read more at govinfonow.com/recall/1764879-radiometer-medical-aps-recalls-the-abl90-flex-and-abl90-flex.

Source Summary by GovInfoNow · govinfonow.com/recall/1764879-radiometer-medical-aps-recalls-the-abl90-flex-and-abl90-flex · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0190-2027

Cite this page

“Radiometer ABL90 FLEX Analyzer May Give Inaccurate Test Results.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764879-radiometer-medical-aps-recalls-the-abl90-flex-and-abl90-flex. Based on FDA recall #Z-0190-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0190-2027%22&limit=1).

The FDA announced on August 18, 2026, that Radiometer Medical ApS is recalling The ABL90 FLEX and ABL90 FLEX PLUS analyzers due to a risk of potentially inaccurate results. Owners must update the instructions for use to address changes in sample types, reportable ranges, configuration, and limitations.

How to tell if you have it

  • Brand: Radiometer
  • Product: ABL90 FLEX Analyzer
  • Product: ABL90 FLEX PLUS Analyzer
  • UDI-DI: 05700693930923, 05700693930909
  • Software versions: 3.6 and lower
  • ABL90 FLEX PLUS Instructions for Use versions prior to: 996-223, Version: 202606O
  • ABL90 FLEX Instructions for Use versions prior to: 996-189, Version: 202606L
  • Units affected: 5,395

The hazard

The in vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use. These changes include that sample types, including whole blood samples, are no longer suitable for testing FHbF and ctBil. The recall also addresses reportable ranges for some parameters, analyzer configuration, and limitations and warnings.

Context

GovInfoNow's records show Radiometer Medical ApS has 17 other recalls on record since February 27, 2018. Other recent recalls of similar products include Cepheid Xpert BCR-ABL Ultra Test Kits (October 30, 2025), Fujirebio Lumipulse G pTau 217 Plasma Calibrators (December 11, 2025), and Siemens Atellica CH A1c_E Hemoglobin Test (February 23, 2026).

How to tell if you have this one

Check for software versions 3.6 or lower on the ABL90 FLEX or ABL90 FLEX PLUS analyzers. The units were sold nationwide in the US starting from 2026 with UDI-DI numbers 05700693930923 and 05700693930909.

  • Brand
    Radiometer
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Look for software version numbers on the device; affected units have versions 3.6 or lower.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL, TX, GA, NC, PA, SC, MI, OK, WI, AR, MN, OR, UT, WA, SD, IN, TN, AZ, NE, WY, KY, AL, AK, ID, NJ, DE, MT, CT, MS, MO, VT, WV, IA, MD, KS, DC, NV, VA, NM,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

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

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Aug 18, 202612. FDA classified it Class II: Oct 15, 202623. Published in FDA’s Enforcement Report: Oct 21, 202634. Added to GovInfoNow: Oct 27, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have an affected unit?

Update the software to a version higher than 3.6 to ensure accurate test results.

Where were these analyzers sold?

Nationwide in the US, including states such as California, New York, Texas, and others.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

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-0190-2027 (August 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0190-2027 to see it in context.
  • Plain-language summary written by qwen3:4b on October 27, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA