Reported Jul 29, 2020 · Terminated
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user…
Sysmex America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sysmex America, Inc. · 577 Aptakisic Rd · Lincolnshire, IL · 60069-4325
Is this the product you have?
- Sysmex PS-10 Sample
- Preparation System Catalog numberBQ716341 -
- Product Usageis a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers
- Lot codes and dates
- Serial Numbers
19060078961907014703190800227419080022731907014704190301196719030119681903011966
- Serial Numbers
- Amount recalled
- 8 units
Where it was sold
Why it was recalled
Insufficient amount of antibody without an error message or alarm
This product could cause temporary or reversible health problems — stop using it.
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