FDA Medical devices recall ·
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6 recall
- Recall number
- Z-1113-2025
- Date
- (initiated January 6, 2025)
- Company / brand
- Sysmex America, Inc.
577 Aptakisic Rd, Lincolnshire, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1113-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.