Device Recall Sysmex StromatolyserIM (SIM220A)

Catalog number SIM-220A, lot numbers C9010, C9011, C9013, C9014, C9015, C9016 and C9017

Hematology and Pathology Devices

1

No

Worldwide Distribution--USA (nationwide) and the countries of Brazil, Canada and Honduras.

Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. || The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.