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FDADecember 18, 2014device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

sysmex

UPCs

11100115483

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear