Jul

2020

Recall – Error message fails to show

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

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