Radiometer E3800 PC Units Spare Parts Recall: Internal Clock Issue
Radiometer recalls spare E3800 PC units (part 910-414) due to internal clock malfunction. Affected units may display incorrect results. Contact Radiometer for replacement.
Lower-risk recall
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Contact the company
What happened, in plain English
Radiometer is recalling spare E3800 PC units (part number 910-414) because their internal clock may malfunction, potentially causing incorrect test results. This does not pose an immediate safety risk but could affect test accuracy. Read more at govinfonow.com/recall/62788-radiometer-e3800-pc-units-spare-parts-recall-internal-clock-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/62788-radiometer-e3800-pc-units-spare-parts-recall-internal-clock-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1858-2021
Cite this page
“Radiometer E3800 PC Units Spare Parts Recall: Internal Clock Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62788-radiometer-e3800-pc-units-spare-parts-recall-internal-clock-issue. Based on FDA recall #Z-1858-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1858-2021%22&limit=1).
Why it’s dangerous
The internal clock issue can cause the analyzer to display incorrect test results. This may lead to inaccurate medical data if the units are used for critical health assessments. However, the problem does not involve physical harm or safety risks.
Who’s affected
Users of Radiometer E3800 PC spare parts who rely on accurate test results. Those using the units for medical testing may be at risk of incorrect results.
How to tell if you have this one
Check if you own spare E3800 PC units with part number 910-414. These units were sold as spare parts for Radiometer analyzers.
- Brand
Radiometer- Category
Medical device
All 3 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
Ongoing- Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, 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, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1856-2021 | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.; Model Number: ABL90 FLEX (393-090) Serial Numbers: ABL90 FLEX analyzers with serial number R0996 R1000, and R1003 onwards | Total=3,346 analyzers world-wide (only 2 analyzers within the U.S.) |
| Z-1857-2021 | Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.; Model Number: ABL90 FLEX PLUS (393-092) Serial Numbers: ABL90 FLEX PLUS analyzers serial numbers R0214 R0218, and R0223 onwards | Total=4,135 analyzers world-wide (only 1277 analyzers within the U.S.) |
| Z-1858-2021 | E3800 PC Units (spare parts); Part number: 910-414 | Total 965 PC units World-wide (only 35 units in the U.S.) |
What to do — step by step
Contact Radiometer
Reach out to Radiometer Medical ApS for replacement or guidance on handling the affected units.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 45 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, 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, SC, SD, TN, TX,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1858-2021 (April 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1858-2021 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.