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Lower risk Medical device recall · FDA · Published February 3, 2020

Radiometer ABL9: Barcode Misread Risk in Lab Testing

Radiometer recalls ABL90 FLEX PLUS analyzers with software below 3.4 MR2 due to barcode misreads causing patient mixups and sample loss. Affected units may delay medical treatment.

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

🇺🇸 FDA recall #Z-1761-2020Medical deviceRadiometer ›
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Contact the company

Recalling firmRadiometer Medical ApSAkandevej 21 · Bronshoj, Denmark
✎ GovInfoNow plain-language explainer

Radiometer is recalling ABL90 FLEX PLUS lab analyzers with software versions below 3.4 MR2 because barcode labels can be misread, potentially causing patient mix-ups or lost samples that delay medical treatment. Read more at govinfonow.com/recall/65904-radiometer-abl9-barcode-misread-risk-in-lab-testing.

Source Summary by GovInfoNow · govinfonow.com/recall/65904-radiometer-abl9-barcode-misread-risk-in-lab-testing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1761-2020

Cite this page

“Radiometer ABL9: Barcode Misread Risk in Lab Testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65904-radiometer-abl9-barcode-misread-risk-in-lab-testing. Based on FDA recall #Z-1761-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1761-2020%22&limit=1).

The FDA announced on Feb. 3, 2020, that Radiometer Medical ApS is recalling ABL90 FLEX PLUS Analyzers due to a barcode reader hazard. The device may misinterpret patient ID barcodes, potentially causing patient mix-ups and delayed medical treatment.

How to tell if you have it

  • Radiometer ABL90 FLEX PLUS Analyzer
  • Model Number 393-092
  • Software versions below 3.4 MR2
  • 3,968 units

The hazard

The firm received reports where the barcode reader misinterpreted locally printed barcode labels used for entering patient ID or accession numbers. This error could result in patient mix-ups and/or loss of samples, leading to delayed medical treatment.

Context

Radiometer Medical ApS has 16 other recalls on record 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), Radiometer ABL800 FLEX Analyzers: Calibration Solution pH Issue (May 31, 2024), and Radiometer AQURE System Software Versions 2.5.2-2.6.1 May Cause Patient Data Mix-Up (March 8, 2023). Other recent recalls of similar products include GEM Premier 5000/7000 Blood Analyzers Risk Patient ID Errors with Bar Code Readers, GEM Premier 5000 Blood Analyzer: Risk of Wrong Patient ID Assignment, and GEM Premier 5000 Blood Analyzer May Assign Results to Wrong Patient ID (all May 8, 2026).

How to tell if you have this one

Check if your ABL90 FLEX PLUS analyzer has a software version below 3.4 MR2. The product is intended for laboratory use, not point-of-care settings.

  • 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 distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Netherlands, China, Croatia, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, South Korea, United Kingdom, Poland, Australia, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
Recall numberProduct, codes & lotsQuantity
Z-1760-2020ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.; software versions below 3.4 MR212,822 units
Z-1761-2020ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.; All software versions below 3.4 MR23,968 units
Based on the official FDA remedy

What to do — step by step

  1. Update Software

    Install software version 3.4 MR2 or later to fix the barcode reading issue.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 48 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: nationwideWYSouth 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: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, OR, PA, RI, SC, SD,…” 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, 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.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Feb 3, 202012. FDA classified it Class II: Apr 22, 202023. Published in FDA’s Enforcement Report: Apr 29, 202034. FDA terminated the recall: Sep 20, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

Is this product safe to use?

The product is safe to use with current software versions, but older versions may cause barcode misreads.

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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-1761-2020 (February 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1761-2020 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.
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