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

Recall Z-0255-2013 — Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screeni

U.S. FDA — Device Enforcement · United States · 2012-06-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0255-2013
Date of alert: 2012-06-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sysmex America, Inc.
Product category: device
Product type: Devices

Reported risk: There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.

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.

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