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.
- Company
- Sysmex America Inc
- Recall Initiated
- July 6, 2020
- Terminated
- May 21, 2021
- Recall Number
- Z-2687-2020
- Quantity
- 8 units
- Firm Location
- Lincolnshire, IL
Reason for Recall
Insufficient amount of antibody without an error message or alarm
Distribution
US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
Lot / Code Info
Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966
Root Cause
Software design
Action Taken
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