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Recall Observatory FDA recall evidence

Device product

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.

Z-2689-2017

May 22, 2017

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 77362
Status
Terminated
Classification
Class II
Quantity
43 units
Official record key
device-enforcement:Z-2689-2017

Official wording

Reason: 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.

Code information: All serial numbers currently in the field

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.