# FDA recall Z-2953-2018

> **Sysmex America, Inc.** · Class II · device recall initiated 2018-07-27.

## 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 analyzers.

## Reason for recall

The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.

## Distribution

Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Honduras,  and Nicaragua.

## Key facts

- **Recall number:** Z-2953-2018
- **Recalling firm:** Sysmex America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-27
- **Report date:** 2018-09-05
- **Termination date:** 2019-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lincolnshire, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2953-2018

## Citation

> AI Analytics. FDA recall Z-2953-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2953-2018. Source: US FDA. Licensed CC0.

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