Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Healgen Series Reagent strips for Urinalysis are composed of several Recalled by Healgen Scientific Llc Due to The reason for this recall is Healgen Scientific...

Date: August 22, 2024
Company: Healgen Scientific Llc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Healgen Scientific Llc directly.

Affected Products

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.

Quantity: 1,636,994 Tests

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Healgen Scientific Llc

Healgen Scientific Llc has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report