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Lower risk Medical device recall · FDA · Published March 22, 2021

Normand Remisol Advance Data Manager Software Recall: Incorrect Rules May Cause Erroneous

Normand recalls software devices that interface lab systems and instruments. Incorrectly programmed rules may cause erroneous lab results. Affected units have catalog numbers B08688, B2:22517, B35058, B74811, B92487.

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

🇺🇸 FDA recall #Z-1831-2021Medical deviceNormand ›
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Contact the company

Recalling firmNormand-Info S.A.S.U.7 rue Frederic Degeorge · Arras CEDEX, France
✎ GovInfoNow plain-language explainer

Normand is recalling its Remisol Advance Data Manager software devices because outdated instructions could lead to incorrectly programmed rules that cause lab results to be wrong. This affects laboratory information systems that interface with lab instruments. Read more at govinfonow.com/recall/63007-normand-remisol-advance-data-manager-software-recall-incorrect-rules-may.

Source Summary by GovInfoNow · govinfonow.com/recall/63007-normand-remisol-advance-data-manager-software-recall-incorrect-rules-may · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1831-2021

Cite this page

“Normand Remisol Advance Data Manager Software Recall: Incorrect Rules May Cause Erroneous.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/63007-normand-remisol-advance-data-manager-software-recall-incorrect-rules-may. Based on FDA recall #Z-1831-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1831-2021%22&limit=1).

The FDA announced on March 22, 2021, that Normand-Info S.A.S.U. is recalling the Normand Remisol Advance Data Manager software device due to insufficient instructions for programming and testing rules. This deficiency may lead to erroneous laboratory results. Owners should contact the company for remedy details.

How to tell if you have it

  • Brand: Normand
  • Product: Normand Remisol Advance Data Manager
  • Catalog Numbers: B08688, B22517, B35058, B74811, B92487
  • Lot Numbers: All Lots
  • Software versions 1.5 to 1.9

The hazard

According to the FDA, the Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results.

Context

GovInfoNow's records show Normand-Info S.A.S.U. has two other recalls on record since August 15, 2019. On April 30, 2020, the company recalled Normand Info Remisol Advance Software 1.12 due to a risk of incorrect blood test results. Other recent recalls of similar products include Beckman Coulter REMISOL Advance Software Issue: Incorrect Test Results Risk (April 29, 2026), Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results Risk (January 30, 2026), and Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (July 15, 2026).

How to tell if you have this one

Check if your software device has catalog numbers B08688, B22517, B35058, B74811, or B92487. The product interfaces lab information systems with laboratory instruments.

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

What to do — step by step

  1. Check Software Version

    Verify your software version is 1.5 to 1.9 to determine if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 30 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: nationwideCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: 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: “Worldwide distribution - US Nationwide distribution in the states of Alabama, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Texas, West Virginia, Wyoming.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Mar 22, 202112. FDA classified it Class II: Jun 8, 202123. Published in FDA’s Enforcement Report: Jun 16, 202134. FDA terminated the recall: Dec 30, 2022420212022
  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.

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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-1831-2021 (March 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1831-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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