Sysmex America, Inc. recalls Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platel…

Recall date

September 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0045-2018

FDA classification

Class II

Brand / firm

Sysmex America, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide including Puerto Rico) Internationally to New Zealand, Brazil, India, Philippines, Nicaragua, Argentina, Australia, Chile, Viet Nam, Colombia, Pakistan, Malaysia, Dubai, Germany, Hong Kong, Bangladesh, Uruguay Thailand, China, Saudi Arabia, Taiwan, Honduras,…

Why it was recalled

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) result and the PLT-F result. In most cases, the falsely decreased PLT-F results display a PLT Abn Scattergram message with an asterisk beside the result or an Action Message: Difference between PLT and PLT- F. Check the results. These are indicators of unreliable data. In rare instances, platelet flags may be absent. The PLT-I results are unaffected.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sysmex Fluorocell(R) PLT 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