SYSMEX CORPORATION TECHNO PARK

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.

Insufficient amount of antibody without an error message or alarm

Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt.

When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.

The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.

There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I…

Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat genera…

There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) v…

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

The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.

The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data ret…

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.