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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.