PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 12, 2017 Initiated: May 22, 2017 #Z-2689-2017

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
43 units
Distribution
Worldwide Distribution
Location
Brea, CA

Frequently Asked Questions

What product 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.. Recalled by Beckman Coulter Inc.. Units affected: 43 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 12, 2017. Severity: Moderate. Recall number: Z-2689-2017.