Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2953-2018·Announced 2018-09-05

Sysmex Fluorocell PLT Reagent Recalled for Inaccurate Platelet Counts

Sysmex America is recalling Fluorocell PLT reagent because it may cause falsely low platelet and immature platelet fraction results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves inaccurate test results without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Sysmex America, Inc. is recalling 5,168 units of Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. This reagent is used to stain platelets in diluted blood samples for counting with Sysmex XN-Series automated hematology analyzers. The recall covers specific reagent lots with expiration dates ranging from January 9, 2019, to February 4, 2019.

The recall is being issued because the fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using the affected lots. This inaccuracy may impact the reliability of hematology test results.

The affected product was distributed nationwide in the United States, including Puerto Rico, as well as in Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras, and Nicaragua. Users should stop using the affected lots and contact Sysmex America for further instructions.

The recalled product

Product: Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology…
Manufacturer: Sysmex America, Inc.
Category: Medical Device — Laboratory Reagent
Hazard: inaccurate-results
Affected units: 5,168

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

Reagent lot numbers: A7125
exp. date 01/9/2019
A7126
exp. date 01/11/2019
A7127
exp. date 01/09/2019
A7128
exp. 01/15/2019
A7129
A7130
exp. 01/17/2019
A7131
A8003
exp. 01/31/2019
A8004
A8005
exp. 02/04/2019
and A8006
exp. 02/04/2019.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Sysmex America, Inc.

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Same hazard · inaccurate results