# FDA recall Z-0045-2018

> **Sysmex America, Inc.** · Class II · device recall initiated 2017-09-08.

## 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

## Reason for recall

There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results  obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) result and the PLT-F result. In most cases, the falsely decreased PLT-F results display a PLT Abn Scattergram message with an asterisk beside the result or an Action Message:  Difference between PLT and PLT- F. Check the results. These are indicators of unreliable data. In rare instances, platelet flags may be absent. The PLT-I results are unaffected.

## Distribution

Worldwide Distribution - US (nationwide including Puerto Rico) Internationally to New Zealand, Brazil, India, Philippines, Nicaragua, Argentina, Australia, Chile, Viet Nam, Colombia, Pakistan, Malaysia, Dubai, Germany, Hong Kong, Bangladesh, Uruguay Thailand, China, Saudi Arabia, Taiwan, Honduras, Ecuador, Kuwait, South Korea, and Costa Rica

## Key facts

- **Recall number:** Z-0045-2018
- **Recalling firm:** Sysmex America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2017-09-08
- **Report date:** 2017-11-01

- **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-0045-2018

## Citation

> AI Analytics. FDA recall Z-0045-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0045-2018. Source: US FDA. Licensed CC0.

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