Class II — Sysmex America, Inc.
| Recalling firm | SYSMEX CORPORATION |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Insufficient amount of antibody without an error message or alarm |
| 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. |
| Quantity | 8 units |
| Distribution | US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL. |
| Initiated | 2020-07-06 |
| Classified | 2020-07-22 |
| Terminated | 2021-05-21 |
| Recall number | Z-2687-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sysmex America, Inc. (Z-2687-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85959/
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