Company: Sysmex America, Inc.
Date of Enforcement Report: 7/29/2020
Class II
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.
Recall Number: Z-2687-2020
REASON
Insufficient amount of antibody without an error message or alarm.
RECALLING FIRM/MANUFACTURER
Sysmex America, Inc. on 7/6/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
U.S. Nationwide