Device 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.
Z-2687-2020
Product summary
- Event
- Event 85959
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-2687-2020
Official wording
Reason: Insufficient amount of antibody without an error message or alarm
Code information: Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966
Distribution pattern: US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
Derived failure modes
-
Unknown
Insufficient amount of antibody without an error message or alarm