Recall Z-1113-2025— Sysmex America, Inc.
Class II · Ongoing
Class II FDA medical device recall by Sysmex America, Inc., initiated 2025-01-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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 on the PS-10 Sample Preparation System..
- Recalling firm
- Sysmex America, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-06
- Firm location
- Lincolnshire, IL, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.