Beckman Coulter recalls Normand Remisol Advance Data Manager software versions 2.0 and 2.1 due to potential for adding extra cells to patient requests, which could cause incorrect lab results. Affected units include specific reference numbers.
“Beckman Coulter Normand Remisol Advance Data Manager Software Recall: Erroneous Patient.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62201-beckman-coulter-normand-remisol-advance-data-manager-software-recall-erroneous. Based on FDA recall #Z-2332-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2332-2021%22&limit=1).
Beckman Coulter, Inc. recalled Normand Remisol Advance Data Manager software devices on July 15, 2021, according to the FDA. The hazard involves potential erroneous patient results due to additional cells being added to patient requests.
How to tell if you have it
Brand: Beckman Coulter
Product: Normand Remisol Advance Data Manager
REF: C69412, C69413, C44703, and C57017
Software Version 2.0 and 2.1
The hazard
The data management system may add additional cells to the patient request which could lead to erroneous patient result.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since June 20, 2017. 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 (Jan. 30, 2026), and Beckman Coulter DxC 700 AU Recall: Delay in Results May Cause Diagnosis Delays (Jan. 30, 2026).
How to tell if you have this one
Check for software versions 2.0 or 2.1 on the Normand Remisol Advance Data Manager. Affected units have reference numbers C69412, C69413, C44703, or C57017.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Normand Remisol Advance Data Manager to see if it is 2.0 or 2.1.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of Al, CA, FL, GA, IL, IN, MA, NC, OH, PA, TN, TX and the countries of Australia, Belgium, Canada, China, Czech Republic, France, Italy, Netherlands, New Zealand, Poland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Illinois, Indiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA terminated this recall 2.9 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-2332-2021 (July 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2332-2021 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.