Z-2687-2020Class II

Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 -

Name: Z-2687-2020 Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 -
Creator: Sysmex America, Inc.
Published: 2020-07-06
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2020-07-06 / Terminated / root cause: software

FDA source

Sysmex America, Inc. began a recall of Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to... on 2020-07-06. FDA classified it as Class II and gives the reason as "Insufficient amount of antibody without an error message or alarm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2687-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-06
Posted: 2020-07-22
Terminated: 2021-05-21
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.
Product code: PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Reason for recall: Insufficient amount of antibody without an error message or alarm
Root cause tag: software
FDA 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 in commerce: 8 units
Distribution: US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
Product codes and lots: Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2687-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2687-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-22

Product code PER

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)