Sysmex XN-Series Fluorocell PLT — Class II medical device recall Z-2953-2018
Terminated recall by Sysmex America, Inc., reported 2018-09-05, distributed nationwide. The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when us
| Recall number | Z-2953-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America, Inc., Lincolnshire, IL, United States |
| Recall initiated | 2018-07-27 |
| Classified | 2018-08-30 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2019-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CL, CR, EC, HN, NI |
| Quantity | 5,168 units |
| Lot numbers | A7125, A7126, A7127, A7128, A7129, A7130, A7131, A8003, A8004, A8005, A8006 |
| Model numbers | CD994563 |
| Expiration dates | 2019-01-09, 2019-01-11, 2019-01-15, 2019-01-17, 2019-01-31, 2019-02-04 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2953-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.