Range Check X II (2015-02-12)

Starting date:

February 12, 2015

Posting date:

March 20, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-52583

• Reason
• Affected products

Recalled products

1. Range Check X II

Reason

Sysmex America, Inc. received complaints from Sysmex installation specialists and customers that level 2 of the five levels of white blood cell (WBC) linearity of range check XII (RCXLL) was recovering above the expected range on the POCH-1 OOI, XP-300 and KX-21 n, and KX-21 analyzers (three-part differential analyzers). Level 2 WBC recovery is expected to be approximately 0.5 +/- 0.5 x10³/uL and recovery was above 1.0 x10³/uL in some instances. When the recovery is above 1.0, the plotted line is not straight suggesting the analyzer is not linear through the entire wbc reportable range of 1.0 to 99.9 x10³/uL for the three part differential analyzers. Exclusion of the level 2 produces a linear graph.

Affected products