Class II — Healgen Scientific Llc
| Recalling firm | HEALGEN SCIENTIFIC LLC |
|---|---|
| Registered facility | HEALGEN SCIENTIFIC LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | 1,636,994 Tests |
| Distribution | U.S. Nationwide distribution in the states of CA, GA and TX. |
| Initiated | 2024-08-22 |
| Classified | 2024-09-27 |
| Recall number | Z-3303-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Healgen Scientific Llc (Z-3303-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95248/
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