Z-0045-2018Class II

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

Name: Z-0045-2018 Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting...
Creator: Sysmex America, Inc.
Published: 2017-09-08
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2017-09-08 / Completed / root cause: manufacturing process

FDA source

Sysmex America, Inc. began a recall of 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... on 2017-09-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0045-2018
Classification: Class II
Status: Completed
Initiated: 2017-09-08
Posted: 2017-10-16
Recalling firm: Sysmex America, Inc.
Product: 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
Product code: KQC Stains, Hematology
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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)
Quantity in commerce: 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, Malaysia, Dubai, Germany, Hong Kong, Bangladesh, Uruguay Thailand, China, Saudi Arabia, Taiwan, Honduras, Ecuador, Kuwait, South Korea, and Costa Rica
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0045-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0045-2018	Class II	Completed	Voluntary: Firm initiated	2017-11-01	2017-10-24

Product code KQC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)