{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-22",
    "results": {
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  "results": [
    {
      "cfres_id": "191333",
      "product_res_number": "Z-0735-2022",
      "event_date_initiated": "2021-12-10",
      "event_date_created": "2022-03-08",
      "recall_status": "Open, Classified",
      "res_event_number": "89362",
      "product_code": "JRC",
      "product_description": "VITROS Chemistry Products VersaTips, Catalog No. 6801715\n\nA VersaTip sales unit is composed of 1000 tips per box.",
      "code_info": "UDI 10758750006786  Lot 1039734",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc.",
      "address_1": "100 Indigo Creek Dr",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626-5101",
      "additional_info_contact": "Mr. Joe Falvo\n585-453-3452",
      "reason_for_recall": "The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On December 10, 2021, the firm notified consignees through ORTHO PLUSSM (a service that provides customers with Ortho Clinical Diagnostics product notifications electronically) of the product issue. Customers were instructed to discontinue use and discard the affected lot. Customers should forward the notification if the product was distributed outside of their facility.",
      "product_quantity": "4125 units",
      "distribution_pattern": "Domestic distribution nationwide. Foreign distribution to Canada.",
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        "device_name": "Micro Pipette",
        "medical_specialty_description": "Clinical Chemistry",
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