Lower riskMedical device recall · FDA · Published May 18, 2022
Radiometer ABL800 Flex Analyzer Recall: Potential Bias in Blood Tests
Radiometer recalls specific ABL800 Flex analyzers with software versions below V6.19 MR2 due to potential bias in blood test results for certain analytes.
“Radiometer ABL800 Flex Analyzer Recall: Potential Bias in Blood Tests.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60695-radiometer-abl800-flex-analyzer-recall-potential-bias-in-blood-tests. Based on FDA recall #Z-1321-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1321-2022%22&limit=1).
The FDA announced on May 18, 2022, that Radiometer Medical ApS is recalling ABL800 Flex Analyzers due to potential biases in test results. The agency issued recall number Z-1321-2022 for the Class II voluntary recall.
How to tell if you have it
Radiometer ABL800 Flex Analyzer, Model Numbers 393-800 and 393-801
All ABL800 Flex Analyzers containing software versions below V6.19 MR2
UDI/DI ABL810, 820, and 830, ABL805, ABL815, ABL825, ABL835: 05700693938004
UDI/DI ABL817, ABL827, ABL837: 05700693938011
The hazard
According to the FDA, there is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Radiometer Medical ApS has 16 other recalls on record since February 27, 2018. Other recent recalls of similar products include Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026) and Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (December 11, 2025).
How to tell if you have this one
Check for model numbers 393-800 or 393-801 on the device. Also, verify if the software version is below V6.19 MR2. The device may have a unique identifier (UDI/DI) starting with 05700693938004 or 05700693938011.
Brand
Radiometer
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on the device; if it is below V6.19 MR2, it is affected.
Contact Radiometer
Reach out to Radiometer Medical ApS for guidance on next steps and potential remedies.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 44 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of 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, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: 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, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1321-2022 (May 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1321-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.