Fluorocell PLT (2017-09-08)

Starting date:

September 8, 2017

Posting date:

October 5, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-64748

• Reason
• Affected products

Affected products

Fluorocell PLT

Reason

There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF %) results performed using affected lots of Fluorocell Plt may exhibit lower than expected PLT-F and IPF values on the XN-Series analyzers. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a "PLT Abn Scattergram" message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected. This instance is a recurrence of a previously reported issue under incident 132547 on July 2016.

Affected products