Houston, TX, United States
Healgen Scientific Llc recalls
1 recall recorded since 2018, most recently on 22 August 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 August 2024
- Reason
- The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.
- Distribution
- U.S. Nationwide distribution in the states of CA, GA and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3303-2024
- Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad a
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.