Fluorocell PLT reagent — Class II medical device recall Z-2770-2016
Terminated recall by Sysmex America Inc, reported 2016-09-21, distributed nationwide. There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed
| Recall number | Z-2770-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America Inc, Lincolnshire, IL, United States |
| Recall initiated | 2016-07-01 |
| Classified | 2016-09-09 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2017-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, DO |
| Quantity | 3,868 units |
| Lot numbers | A5041, A5042, A5044, A5046, A5047, A5048, A5049, A5050, A5053, A5054, A5055 |
| Model numbers | CD994563 |
| Expiration dates | 2016-09-02, 2016-10-02, 2016-11-09, 2016-11-17, 2016-11-26, 2016-12-21, 2016-12-24 |
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
Reason for recall
There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The 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 beside the results indicating the data is unreliable. 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. As such, 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.
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-2770-2016. 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.