🔍 RecallPedia

Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (FC500, Navios and Navios EX). The COULTER PrepPlus 2 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.

Class I - Dangerous
🏥 Medical Devices Recalled: May 22, 2017 Beckman Coulter Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    All serial numbers currently in the field
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Beckman Coulter Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (FC500, Navios and Navios EX). The COULTER PrepPlus 2 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.

Product Codes/Lot Numbers:

All serial numbers currently in the field

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2690-2017

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