FDA-Device2017-07-12Class II

Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

Beckman Coulter Inc.
Hazard

When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.

Sold states
Worldwide Distribution
Affected count
43 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2689-2017

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