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  "name": "Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.",
  "description": "FDA recall Z-1075-2024 — Microbiologics Inc is recalling Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. (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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    "name": "Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.",
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      "name": "FDA recall Z-1075-2024: Microbiologics Inc is recalling Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.",
      "text": "The FDA logged enforcement record Z-1075-2024: Microbiologics Inc is voluntarily recalling Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. — reason: The negative control was contaminated with one of the positive control pathogens (Norovirus).  This would result in users getting a positive call for Norovirus when running the negative control.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-08. Affected lots/codes: Lot #8184-68, Exp. 5/31/2025, UDI-DI 70845357041448.  UPDATE:  The recall was expanded on 1/23/2024 to include the following additional lot numbers:  8184-65, exp. 3/31/2025; 8184-66, exp. 4/30/2025; 8184-67, exp. 5/31/2025; 8184-69, exp. 6/30/2025; 8184-70, exp. 8/31/2025; and 8184-71, exp. 8/31/2025.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1075-2024 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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      "@type": "schema:Claim",
      "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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      "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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            "Field": "Reason",
            "Value": "The negative control was contaminated with one of the positive control pathogens (Norovirus).  This would result in users getting a positive call for Norovirus when running the negative control.",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Lot #8184-68, Exp. 5/31/2025, UDI-DI 70845357041448.  UPDATE:  The recall was expanded on 1/23/2024 to include the following additional lot numbers:  8184-65, exp. 3/31/2025; 8184-66, exp. 4/30/2025; 8184-67, exp. 5/31/2025; 8184-69, exp. 6/30/2025; 8184-70, exp. 8/31/2025; and 8184-71, exp. 8/31/2025.",
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