—#155841

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.

FDA product code: PER — Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K130253
Affected lot / code info: All serial numbers currently in the field

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.

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm initiated their recall by letter disseminated via email on 05/22/2017. The letter requested the following actions be taken: 1. Insert an empty daughter tube in place of a patient sample as the first tube in the carousel that is programmed for the addition of Flow-Count Fluorospheres. 2. Refer to the COULTER PrepPlus Operators Guide / PrepPlus 2 Instructions for Use (IFU) for instructions on adding Flow-Count Fluorospheres to daughter tubes. 3. Review all results following the flow cytometer data review instructions referenced in the associated IFU. Beckman Coulter also requested the consignee share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If the consignee forwarded any of the affected product(s) listed above to another laboratory, They were asked to provide them a copy of the letter.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2017-05-22
Terminated: 2021-03-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155841. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.