Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for a
Summary
The FDA issued a Class II for Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catal by Sysmex America, Inc.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-1113-2025
Action Date
2025-02-12
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI-DI: 04987562501908; Serial Numbers: 1908002275 1908002276 1908009775 1910009588 1910011295 1912002638 2103013913 2108004629 2108004630 2108004631 2108004632 2112005423 2112005425 2203014206 2203014207 2203014208 2205012732 2205012734 2206005973 2206012294 2208015835 2210003722 2210003723 2210003724 2212010048 1903011966 1903011968 1910009589 1912002640 2103013912 2208015834 1903011967
Quantity Affected: 32 units
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.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-06
Company
Lincolnshire, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Sysmex America, Inc. has 7 FDA actions in our database, including 2 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sysmex America, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sysmex America, Inc. have FDA actions?
Sysmex America, Inc. has 7 FDA actions in our database, including 2 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1113-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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