Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 — Class II medical device recall Z-2687-2020
Terminated recall by Sysmex America, Inc., reported 2020-07-29, distributed nationwide. Insufficient amount of antibody without an error message or alarm
| Recall number | Z-2687-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America, Inc., Lincolnshire, IL, United States |
| Recall initiated | 2020-07-06 |
| Classified | 2020-07-22 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2021-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
| Serial numbers | 1903011966, 1903011967, 1903011968, 1906007896, 1907014703, 1907014704, 1908002273, 1908002274 |
| Model numbers | BQ716341 |
Product
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
Reason for recall
Insufficient amount of antibody without an error message or alarm
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-2687-2020. 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.