Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 Z-2687-2020

U.S. FDA — Device Enforcement · United States · 2020-07-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2687-2020
Date of alert
2020-07-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sysmex America, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
1906007896
Reported risk: Insufficient amount of antibody without an error message or alarm
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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