Sysmex recalls XN-Series Fluorocell PLT reagents that may show falsely low platelet counts, affecting blood test accuracy. Affected lots have specific expiration dates.
The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
Sysmex is recalling certain Fluorocell PLT reagents used in blood tests because they can give falsely low platelet counts. This could lead to incorrect test results if the affected reagents are used.
The reagents can produce false low platelet counts when used in Sysmex XN-Series analyzers. This means test results might show fewer platelets than actually present, potentially leading to incorrect diagnoses.
Lab users who have the affected reagent lots (A7125 to A8006) may get inaccurate blood test results. Healthcare professionals and labs using these reagents are most at risk.
Check the reagent lot numbers on the packaging: A7125 through A8006. These lots were distributed with specific expiration dates between January 9, 2019 and February 4, 2019.
Look for lot numbers A7125 to A8006 on the Fluorocell PLT reagent packaging.
Using affected lots can cause false low platelet counts, which might lead to incorrect blood test results.
Affected lots are A7125 through A8006, with expiration dates from January 9, 2019 to February 4, 2019.
No action is required for the reagents themselves; you only need to check if your lot numbers match the affected range.
We’ve drafted a message you can send Sysmex to request your refund or repair — edit it as you like.
Subject: Recall Z-2953-2018 — Sysmex Sysmex Hello, I own a Sysmex that is covered by recall Z-2953-2018 from Sysmex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
