Sysmex PS-10 Sample Preparation System with software version 1 — Class II medical device recall Z-1113-2025
Ongoing recall by Sysmex America, Inc., reported 2025-02-12, distributed nationwide. Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the pr
| Recall number | Z-1113-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America, Inc., Lincolnshire, IL, United States |
| Recall initiated | 2025-01-06 |
| Classified | 2025-02-05 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 32 units |
| UPC / GTIN / UDI-DI | 04987562501908 |
| Serial numbers | 1903011966, 1903011967, 1903011968, 1908002275, 1908002276, 1908009775, 1910009588, 1910009589, 1910011295, 1912002638, 1912002640, 2103013912, 2103013913, 2108004629, 2108004630, 2108004631, 2108004632, 2112005423, 2112005425, 2203014206, 2203014207, 2203014208, 2205012732, 2205012734, 2206005973 and 7 more |
| Model numbers | BQ716341 |
Product
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
Reason for recall
Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
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-1113-2025. 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.