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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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