Sysmex PS-10 Sample Preparation System recall
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use…
Why was Sysmex PS-10 Sample Preparation System recalled?
Insufficient amount of antibody without an error message or alarm
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966
- Product
- Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use…
- Recalling firm
- Sysmex America, Inc.
- Quantity
- 8 units
- Distribution
- US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
- Recall date
- July 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)