XN CHECK (2020-04-09)

Starting date:

April 9, 2020

Posting date:

May 1, 2020

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-72931

Last updated: 2020-05-01

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  Reason
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  Affected products

Affected Products

XN CHECK

Reason

Sysmex America, Inc. (SAI) recognized a trend with complaints from XN-series customers reporting a decrease in the recovery of fluorescent platelet (PLT-F) and absolute Immature Platelet Fraction (IPF#) parameters with the XN CHECK, Level 1 hematology control Lot sequence 0062, 0063, 0064 and 0065. Lot 0062 and 0065 were distributed to Canadian customers beginning March 2, 2020.

Affected products