Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platele

FDA device recall Z-0045-2018 · posted 2017-10-16 · Completed

Recall details

Recalling firm

Sysmex America, Inc.

Reason for recall

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.

Action taken

Sysmex sent a Customer Letter dated August 2017 to all affected customers. The customer was directed to examine their inventory for the affected lot numbers and report back to Sysmex. .Customers with questions should call 1-888-879-7639, option 2 (if within the U.S.) or 1-888-679-7639 (for customers in Canada)

Root cause

Nonconforming Material/Component

Status

Completed

Product code

KQC

Quantity affected

23,239 units (9353 US)

Distribution

Worldwide Distribution - US (nationwide including Puerto Rico) Internationally to New Zealand, Brazil, India, Philippines, Nicaragua, Argentina, Australia, Chile, Viet Nam, Colombia, Pakistan, Malaysi

Date initiated

2017-09-08

Date posted

2017-10-16

Location

Lincolnshire, IL