Sysmex Fluorocell PLT Recall: Incorrect Platelet Results Risk Unreliable Blood Tests
Sysmex America recalls Fluorocell PLT test kits with lot numbers A6051-A6090. These kits may cause false low platelet results, leading to inaccurate blood test counts. Affected users should check for error messages in their Sysmex XN-Series analyzers.
Lower-risk recall
There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) result and the PLT-F result. In most cases, the falsely decreased PLT-F results display a PLT Abn Scattergram message with an asterisk beside the result or an Action Message: Difference between PLT and PLT- F. Check the results. These are indicators of unreliable data. In rare instances, platelet flags may be absent. The PLT-I results are unaffected.
Contact the company
What happened, in plain English
Sysmex Fluorocell PLT test kits (lot numbers A6051-A6090) may produce false low platelet results, causing unreliable blood test counts. This could lead to incorrect medical decisions if not addressed. Read more at govinfonow.com/recall/73048-sysmex-fluorocell-plt-recall-incorrect-platelet-results-risk-unreliable-blood.
Source Summary by GovInfoNow · govinfonow.com/recall/73048-sysmex-fluorocell-plt-recall-incorrect-platelet-results-risk-unreliable-blood · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0045-2018
Cite this page
“Sysmex Fluorocell PLT Recall: Incorrect Platelet Results Risk Unreliable Blood Tests.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73048-sysmex-fluorocell-plt-recall-incorrect-platelet-results-risk-unreliable-blood. Based on FDA recall #Z-0045-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0045-2018%22&limit=1).
Why it’s dangerous
The Fluorocell PLT kits may show falsely decreased platelet counts, leading to inaccurate blood test results. This can cause a large discrepancy between impedance platelet (PLT-I) and fluorescent platelet (PLT-F) results. In rare cases, the analyzer may not flag errors, but the PLT-I results remain accurate.
Who’s affected
Users of Sysmex XN-Series blood analyzers with the recalled Fluorocell PLT kits (lot numbers A6051-A6090) are affected. Healthcare providers and labs using these kits for blood testing are most at risk.
How to tell if you have this one
Check your Sysmex XN-Series analyzer for lot numbers A6051 through A6090 on the Fluorocell PLT kits. The issue may be recognized by error messages like 'PLT Abn Scattergram' or 'Difference between PLT and PLT-F. Check the results.'
- Brand
Sysmex- Category
Medical device
What to do — step by step
Check for Error Messages
Look for error messages such as 'PLT Abn Scattergram' or 'Difference between PLT and PLT-F. Check the results' in your Sysmex XN-Series analyzer.
Verify Kit Lot Numbers
Confirm your Fluorocell PLT kit lot numbers are within A6051-A6090 to determine if affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US (nationwide including Puerto Rico) Internationally to New Zealand, Brazil, India, Philippines, Nicaragua, Argentina, Australia, Chile, Viet Nam, Colombia, Pakistan, Malaysia, Dubai, Germany, Hong Kong,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 54 days 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.
Questions people ask
Do I need to stop using the Fluorocell PLT kits?
No, the recall does not require stopping use. The kits may produce inaccurate results but do not cause physical harm.
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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-0045-2018 (September 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0045-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 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.