Sysmex Fluorocell PLT Reagent Recalled for Potential Inaccurate Platelet Results
Sysmex America is recalling Fluorocell PLT reagent lots because they may produce falsely low platelet results, potentially affecting diagnostic accuracy.
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, but the source text describes a potential for inaccurate data (falsely low results) without reporting any specific patient injuries, hospitalizations, or deaths. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary measures where harm has not been explicitly reported.
Plain-English summary
Sysmex America, Inc. is recalling 23,239 units of Sysmex Fluorocell(R) PLT reagent. This product is used to stain platelets in diluted blood samples for counting with Sysmex XN-Series automated hematology analyzers. The recall covers specific lot numbers (A6051 through A6090) distributed nationwide in the US (including Puerto Rico) and internationally to numerous countries.
The recall is issued because there is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF) results obtained using these lots may be lower than the actual values. This issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) result and the PLT-F result. In most cases, falsely decreased PLT-F results display a 'PLT Abn Scattergram' message with an asterisk or an Action Message indicating a difference between PLT and PLT-F. These are indicators of unreliable data, though in rare instances, platelet flags may be absent. The PLT-I results are unaffected.
Healthcare facilities and laboratories using these specific lots should stop using the affected reagent and contact Sysmex America for instructions on how to proceed. The recall is limited to the specific lot numbers listed in the agency's documentation.
The recalled product
- 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
- Manufacturer
- Sysmex America, Inc.
- Hazard
Distribution
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