Reported Jun 22, 2016 · Terminated
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in…
Sysmex Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sysmex Corporation · 1 5 1 Wakinohamakaigandoori · Kobe-shi · N/A
Is this the product you have?
- 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.
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published XN-10— AP795756— — Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484 XN-20— AE797961— — Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117. - Amount recalled
- 1,137 units (US) 54 units (Canada) 9 inventory
Where it was sold
Why it was recalled
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
This product could cause temporary or reversible health problems — stop using it.
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