{
  "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,
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  "results": [
    {
      "cfres_id": "197251",
      "product_res_number": "Z-0739-2023",
      "event_date_initiated": "2022-11-22",
      "event_date_posted": "2022-12-20",
      "recall_status": "Open, Classified",
      "res_event_number": "91202",
      "product_code": "QJR",
      "product_description": "Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096",
      "code_info": "Lot Numbers:  381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499",
      "firm_fei_number": "3005248192",
      "recalling_firm": "Abbott Molecular, Inc.",
      "address_1": "1300 E Touhy Ave",
      "city": "Des Plaines",
      "state": "IL",
      "postal_code": "60018-3315",
      "additional_info_contact": "Ray Bastian\n224-206-4102",
      "reason_for_recall": "Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Abbott Molecular issue an Urgent Field Safety Notice /Field Correction Recall to its consignees on 11/22/2022 by FedEx priority express.  The notice explained the issue and requested the following actions:  \n\"- Discard inventory of any lots listed in Appendix A below.  Contact Abbott Customer\nSupport for credit of any unused kit(s).\n- If you have forwarded any kits of these lots to other laboratories, please inform them of this Urgent Field Safety Notice /Field Correction Recall, and provide a copy of this letter.\n- Return the associated Customer Reply form.\n\nPlease review this information with laboratory personnel and retain this communication for future reference.  If you have any questions regarding this communication, please contact your local Abbott representative, or call Abbott Technical Support at 1-800-55-7042 Option 2.\"",
      "product_quantity": "3896 kits",
      "distribution_pattern": "Worldwide",
      "openfda": {
        "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N",
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