{
  "format": "devicerts.device.v1",
  "cite_as": "Vacuette 455092, Greiner Bio - One GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/vacuette-455092 (data as of 2026-11-15).",
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    "registry_records_last_synced": "2026-10-23",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/vacuette-455092",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
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      "country_basis": null,
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    "status": {
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      "reason": "Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing.  This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.",
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    {
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      "applies": "this device",
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    },
    {
      "number": "Z-0818-2020",
      "classification": "Class II",
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      "reason": "The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area.  This may lead to a vacuum loss and tubes not filling up to the proper volume.",
      "applies": "this device",
      "via": "K983952"
    },
    {
      "number": "Z-0086-06",
      "classification": "",
      "status": "terminated",
      "initiated": "2005-07-28",
      "reason": "Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.",
      "applies": "this device",
      "via": "K960858"
    }
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}