Recall Z-2687-2020— Sysmex America, Inc.
Class II · Terminated
Class II FDA medical device recall by Sysmex America, Inc., initiated 2020-07-06, terminated 2021-05-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Insufficient amount of antibody without an error message or alarm.
- Recalling firm
- Sysmex America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-06
- Terminated
- 2021-05-21
- Firm location
- Lincolnshire, IL, United States
Product description
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.
Reason for recall
Insufficient amount of antibody without an error message or alarm
Data sourced from openFDA. This site is unofficial and independent of the FDA.