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  "name": "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.",
  "description": "FDA recall Z-3303-2024 — Healgen Scientific Llc is recalling 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. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "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.",
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      "name": "Healgen Scientific Llc"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3303-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3303-2024: Healgen Scientific Llc is recalling 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.",
      "text": "The FDA logged enforcement record Z-3303-2024: Healgen Scientific Llc is voluntarily recalling 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: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-22. Affected lots/codes: Product Item Code: Urinox-P30  UDI-DI code: 196852593453 Lot Number: N2310003 N2310012 N2305013 N2308006 N2209013 N2302034 N2303002  Product Item Code: URS-11T   UDI-DI code: 00816490024347 Lot Number: N2311002 N2306012  Product Item Code: Urinox10-30    UDI-DI code: 099654011043 Lot Numbers: N2311004 N2305015 N2305025 N2308011 N2309011 N2302027 N2302032  Product Item Code: URS-10T    UDI-DI code: 00816490024323 Lot Numbers: N2311007 N2306001 N2306013 N2308004 N2309002 N2211004  Product Item Code: Urinox10-20     UDI-DI code: 707486987534 Lot Numbers: N2305014 N2305024 N2308010 N2309010 N2302031  Product Item Code: Urinox-10-60      UDI-DI code: 707486987053 Lot Numbers: N2305026 N2306006 N2308012 N2302028 N2302033  Product Item Code: URS-4T       UDI-DI code: 00816490024330 Lot Number: N2306014. A RECORDED FDA enforcement action (occurred=true).",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-3303-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Value": "Z-3303-2024",
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Value": "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.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-08-22",
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            "Value": "Product Item Code: Urinox-P30  UDI-DI code: 196852593453 Lot Number: N2310003 N2310012 N2305013 N2308006 N2209013 N2302034 N2303002  Product Item Code: URS-11T   UDI-DI code: 00816490024347 Lot Number: N2311002 N2306012  Product Item Code: Urinox10-30    UDI-DI code: 099654011043 Lot Numbers: N2311004 N2305015 N2305025 N2308011 N2309011 N2302027 N2302032  Product Item Code: URS-10T    UDI-DI code: 00816490024323 Lot Numbers: N2311007 N2306001 N2306013 N2308004 N2309002 N2211004  Product Item Code: Urinox10-20     UDI-DI code: 707486987534 Lot Numbers: N2305014 N2305024 N2308010 N2309010 N2302031  Product Item Code: Urinox-10-60      UDI-DI code: 707486987053 Lot Numbers: N2305026 N2306006 N2308012 N2302028 N2302033  Product Item Code: URS-4T       UDI-DI code: 00816490024330 Lot Number: N2306014",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the states of CA, GA and TX.",
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