FDA Medical Device Recalls (openFDA)
Sysmex America, Inc.: 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.
- Recall number
- Z-2687-2020
- Recalling firm
- Sysmex America, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-07-06
- Posted
- not on file
- Terminated
- 2021-05-21
- Reason
- Insufficient amount of antibody without an error message or alarm
- Root cause
- Software design
- Action
- Sysmex issued a field corrective action on July 6, 2020. The product notification states the following actions to be taken: 1. A Sysmex Service Engineer will be scheduled to adjust the probe height to correct the issue from occurring when using the Sysmex antibody vials. The PS-10 should not be used to perform any testing, other than internal validation, until the adjustment is completed. 2. Discontinue use of non-Sysmex antibody vials in the PS-10 for testing until Sysmex hascompleted the verification, unless your internal procedures ensure the required accuracy of the pipetted volume. 3. Please distribute this Product Notification as appropriate to your laboratory 4. File this Product Notification as a part of your laboratorys Quality System as required For urgent requests, call the Technical Assistance Center at 1-888-879- 7639 in the U.S., or at 1-888-679-7639 in Canada
- Quantity
- 8 units
- Distribution
- US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
- Lot, serial or model codes
- Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PER
- Firm FEI
- 3009711478
- Firm city
- Lincolnshire
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28