{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "189702",
      "product_res_number": "Z-0162-2022",
      "event_date_initiated": "2021-09-23",
      "event_date_created": "2021-10-21",
      "recall_status": "Open, Classified",
      "res_event_number": "88825",
      "product_code": "QJR",
      "product_description": "SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051",
      "code_info": "Lot #/Expiration Date:  12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022",
      "firm_fei_number": "2023365",
      "recalling_firm": "DiaSorin Molecular LLC",
      "address_1": "11331 Valley View St",
      "city": "Cypress",
      "state": "CA",
      "postal_code": "90630-5366",
      "additional_info_contact": "Diasorin Molecular Technical Service\n714-220-1900",
      "reason_for_recall": "Due to unapproved raw materials  used in the manufacturing  of Covid-19 control pack, their is the potential for delayed amplification signals.",
      "root_cause_description": "Process control",
      "action": "On September 23, 2021, DiaSorin Molecular issued a field courtesy notification letter via email.   On October 18, 2021, DiaSorin issued a \"Urgent: Medical Device Correction\" notification   to provide additional details concerning the recall. In addition to informing consignees about the correction, DiaSorin asked consignees to take the following actions:\n\n1. A run with a failed positive control should be repeated per the IFU instructions.\n2. Please be sure to notify others within your network that may have received these kits.\n3. Please complete and return the Acknowledgement and Receipt Form (page 2) of this notification letter.\n4. If your firm has further distributed the devices, please share a copy of this correction notification and response form with those customers and provide a copy of the completed response form back us.\n5. If you have any questions or if you have experienced an invalid Positive Control run and would like replacement product for the tests that were invalid due to this, please contact DiaSorin Molecular Technical Service, Mon-Fri, 7:00 AM to 5:00 PM (Pacific Time) at (800) 838-4548, option 3, or by email at ts.molecular@DiaSorin.com.\n6.  Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.",
      "product_quantity": "1690 kits",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Italy.",
      "openfda": {
        "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N",
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