Recall Record

Atlanta, GA, United States

Centers For Disease Control and Prevention recalls

1 recall recorded since 2018, most recently on 26 April 2024. 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
26 April 2024
Terminated
5 February 2025
Reason
The H5b component may fail to amplify, resulting in an inconclusive result.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-2220-2024

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.