Sysmex Fluorocell — Class II medical device recall Z-0045-2018
Completed recall by Sysmex America, Inc., reported 2017-11-01, distributed nationwide. There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained
| Recall number | Z-0045-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America, Inc., Lincolnshire, IL, United States |
| Recall initiated | 2017-09-08 |
| Classified | 2017-10-24 |
| Reported by FDA | 2017-11-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BD, BR, CL, CN, CO, CR, DE, EC, HK, HN, IN, KR, KW, MY, NI, NZ, PH, PK, SA, TH, TW, UY, VN |
| Lot numbers | A6051, A6052, A6053, A6054, A6055, A6056, A6057, A6058, A6059, A6060, A6061, A6062, A6063, A6064, A6065, A6066, A6067, A6068, A6069, A6070, A6071, A6072, A6073, A6074, A6075, A6076, A6077, A6078, A6079, A6080, A6081, A6082, A6083, A6084, A6085, A6086, A6087, A6088, A6089, A6090 |
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.
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-0045-2018. 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.