The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2770-2016·Announced 2016-09-21

Sysmex Fluorocell PLT Reagent Recalled for Potential Low Platelet Results

Sysmex America Inc is recalling Fluorocell PLT reagent because it may produce falsely low platelet results on Sysmex XN-Series analyzers.

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 source explicitly states the likely impact to patient results is low and the hazard is a potential for inaccurate data rather than a direct physical injury or high-risk pathogen, fitting the Moderate category for low-risk issues.

Plain-English summary

Sysmex America Inc is recalling Fluorocell PLT reagent, Catalog #CD994563, used to stain platelets in diluted blood samples for counting with Sysmex XN-Series automated hematology analyzers. The recall involves 3,868 units distributed worldwide, including the United States, Canada, Cuba, Chile, and the Dominican Republic. Specific lot numbers and expiration dates are listed in the recall notice.

The recall is due to a potential issue where fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results may exhibit lower than expected values. This issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a "PLT Abn Scattergram" message with asterisks indicating the data is unreliable, though in rare instances, platelet flags may be absent. The PLT-I counts are unaffected.

The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. The source states that the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.

The recalled product

Product
Fluorocell PLT reagent, Catalog #CD994563 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
Category
Medical Device — Laboratory Reagent
Hazard
Affected units
3,868

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 (12)

  • Lot number A5053
  • Expiration date 12/21/2016 Lot number A5054
  • Expiration date 12/21/2016 Lot number A5041
  • Expiration date 9/2/2016 Lot number A5042
  • Expiration date 9/2/2016 Lot number A5044
  • Expiration date 10/2/2016 Lot number A5046
  • Expiration date 11/9/2016 Lot number A5047
  • Expiration date 11/17/2016 Lot number A5048
  • Expiration date 11/17/2016 Lot number A5049
  • Expiration date 11/26/2016 Lot number A5050
  • Expiration date 11/26/2016 Lot number A5055
  • Expiration date 12/24/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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