Recall Record

Lawrenceville, GA, United States

LW Scientific, Inc. recalls

1 recall recorded since 2018, most recently on 6 February 2019. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Medical devices

Recall started
6 February 2019
Terminated
7 May 2021
Reason
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
Distribution
Worldwide Distribution - US Nationwide and the countries of Philippines, Honduras, El Salvador, Australia, Guatemala, Canada, Singapore, Australia, Peru, Nicaragua, Trinidad and Tobago, and New Zealand
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1048-2019, Z-1050-2019, Z-1049-2019

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.