# FDA recall Z-3303-2024

> **Healgen Scientific Llc** · Class II · device recall initiated 2024-08-22.

## Product

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 and comparing with the corresponding blocks on a color chart.  The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.

## Reason for recall

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.

## Key facts

- **Recall number:** Z-3303-2024
- **Recalling firm:** Healgen Scientific Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-22
- **Report date:** 2024-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3303-2024

## Citation

> AI Analytics. FDA recall Z-3303-2024. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-3303-2024. Source: US FDA. Licensed CC0.

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