FDAClass IIJuly 12, 2017

Coulter PrepPlus recall

Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for…

Why was Coulter PrepPlus 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.

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?

All serial numbers currently in the field

Product
Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for…
Recalling firm
Beckman Coulter Inc.
Quantity
43 units
Distribution
Worldwide Distribution
Recall date
July 12, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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