Recall StatusCompleted
Date Initiated2017-09-08
Product Quantity23,239 units (9353 US)
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.
Firm Action
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
Distribution Pattern
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, Ecuador, Kuwait, South Korea, and Costa Rica
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.