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.
What this means for you
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 analyzer
- Manufacturer
- Sysmex America, Inc.
- Hazard
- 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
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