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U.S. Department of Health and Human Services

Class 2 Device Recall Sysmex Fluorocell(R) PLT

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 Class 2 Device Recall Sysmex Fluorocell(R) PLTsee related information
Date Initiated by FirmSeptember 08, 2017
Date PostedOctober 16, 2017
Recall Status1 Completed
Recall NumberZ-0045-2018
Recall Event ID 78134
Product Classification Stains, hematology - Product Code KQC
ProductSysmex 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
Code Information Lot Numbers: A6051 A6052 A6053 A6054 A6055 A6056 A6057 A6058 A6059 A6060 A6061 A6062 A6063 A6064 A6065 A6066 A6067 A6068 A6069 A6070 A6071 A6072 A6073 A6074 A6075 A6076 A6077 A6078 A6079 A6080 A6081 A6082 A6083 A6084 A6085 A6086 A6087 A6088 A6089 A6090   
FEI Number 3009711478
Recalling Firm/
Manufacturer		 Sysmex America, Inc.
577 Aptakisic Rd
Lincolnshire IL 60069-4325
For Additional Information ContactSysmex Customer Service
224-543-9514
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSysmex 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)
Quantity in Commerce23,239 units (9353 US)
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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