Sysmex Corporation Recalls

Overview of recall records associated with Sysmex Corporation, including dates, categories and classifications where available.

1recall records

Jun 22, 2016latest record date

Jun 22, 2016earliest record date

Recall history in this database

Classification mix: Class II: 1.

Medical DeviceJun 22, 2016

Sysmex The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated recall — FDA Z-1945-2016

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

Class IIFDA: TerminatedSysmex Corporation

Understanding this recall history

This page summarizes recall records in which the official source identifies Sysmex Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.