Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1945-2016 — The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

U.S. FDA — Device Enforcement · Japan · 2014-12-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1945-2016
Date of alert: 2014-12-18
Country / jurisdiction: Japan
Risk level: Class II
Risk type: recall
Brand: Sysmex Corporation
Product category: device
Product type: Devices

Reported risk: There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1945-2016 — The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

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