Medical device recalls Moderate risk

Beckman Coulter Inc. recalls Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and…

Recall date
May 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2689-2017
FDA classification
Class II
Brand / firm
Beckman Coulter Inc.
Sold / distributed
Worldwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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