{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "195729",
      "product_res_number": "Z-1679-2022",
      "event_date_initiated": "2022-08-19",
      "event_date_created": "2022-09-06",
      "recall_status": "Open, Classified",
      "res_event_number": "90789",
      "product_code": "QJR",
      "product_description": "Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.",
      "code_info": "Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.",
      "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\n224-361-7000",
      "reason_for_recall": "Reports received of an increase of message code 9186 (internal control failed) when using the kit.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm issued recall letters dated 8/19/2022 via FedEx priority overnight express on 8/19/2022.  The letters provided the background, potential impact, and necessary actions.  The necessary actions included contacting Abbott Customer Support for replacement of any unused kits in the consignee's inventory of the affected lot number and discard any inventory in their possession.  If replacement inventory is not available, the consignee was told they may continue to use the affected product until replacement material is obtained.  They are to ensure that valid Control values are obtained for all control levels prior to reporting results as specified in the associated package Insert.  A Customer Reply Form was enclosed for completion and return.  If the consignee has forwarded any kits of the affected lot to other laboratories, they are instructed to inform them of the recall, provide them a copy of the letter, and have them take the necessary actions listed.  The letter also instructs the consignee to inform their laboratory personnel of the issue and retain a copy of the communication for further reference.",
      "product_quantity": "579 kits",
      "distribution_pattern": "Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI.  There was government distribution but no military distribution.\n\nForeign distribution was made to Chile and Taiwan.",
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        "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}