Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers

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) 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. The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. As such, the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.

Sysmex sent a Product Notification Letter dated August 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. . Customers were instructed to cease use and discard the affected lots, and reply to Sysmex America, Inc. using the provided fax-back form. An updated Product Notification (Attachment 1) was mailed to all XN-Series customers on August 12, 2016 informing them of the additional recalled lots. This notification included the phone number for the Technical Assistance Center at 1-888-879-7639 in the U.S., and 1-888-679-7639 in Canada.