Healgen Series Reagent strips for Urinalysis are composed of several… — Class II medical device recall Z-3303-2024
Ongoing recall by Healgen Scientific Llc, reported 2024-10-09, distributed nationwide. The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products
| Recall number | Z-3303-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Healgen Scientific Llc, Houston, TX, United States |
| Recall initiated | 2024-08-22 |
| Classified | 2024-09-27 |
| Reported by FDA | 2024-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,636,994 tests |
| UPC / GTIN / UDI-DI | 00099654011043, 00196852593453, 00707486987053, 00707486987534, 00816490024323, 00816490024330, 00816490024347 |
| Lot numbers | N2209013, N2211004, N2302027, N2302028, N2302031, N2302032, N2302033, N2302034, N2303002, N2305013, N2305014, N2305015, N2305024, N2305025, N2305026, N2306001, N2306006, N2306012, N2306013, N2306014, N2308004, N2308006, N2308010, N2308011, N2308012, N2309002, N2309010, N2309011, N2310003, N2310012, N2311002, N2311004, N2311007 |
| Model numbers | URINOX-10-60, URINOX-P30, URINOX10-20, URINOX10-30, URS-10T, URS-11T, URS-4T |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3303-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.