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.
Reported: July 29, 2020 Initiated: July 6, 2020 #Z-2687-2020
Product Description
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.
Reason for Recall
Insufficient amount of antibody without an error message or alarm
Details
- Recalling Firm
- Sysmex America, Inc.
- Units Affected
- 8 units
- Distribution
- US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
- Location
- Lincolnshire, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sysmex America, Inc.. Units affected: 8 units.
Why was this product recalled? ▼
Insufficient amount of antibody without an error message or alarm
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2020. Severity: Moderate. Recall number: Z-2687-2020.
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