{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "203603",
      "product_res_number": "Z-0215-2024",
      "event_date_initiated": "2023-04-24",
      "event_date_posted": "2023-11-02",
      "recall_status": "Open, Classified",
      "res_event_number": "93125",
      "product_code": "PGX",
      "k_numbers": [
        "K172126"
      ],
      "product_description": "Xpert Xpress Strep A,  XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only",
      "code_info": "UDI: (01)07332940006372/ Lots:     23718\t23719\t23720\t10309\t23201\t23305\t23308\t23312\t23314\t23315\t23401\t23402\t23403\t23404\t23405\t23406\t23407\t23501\t23504\t23505\t23506\t23408\t23410\t23510\t23411\t23604\t23605\t23607\t23608\t23609\t23610\t23611\t23612\t23701\t23702\t23703\t23705\t23706\t23707\t23708\t23709\t23710\t23711\t23712\t23714\t23716\t23717\t23113\t23316\t23912\t24112\t23820\t24704\t24302\t24307\t24507\t24508\t24511\t23822\t23823\t23824\t24512\t24513\t24514\t23825\t24313\t24515\t24516\t24517\t24805",
      "firm_fei_number": "3004530258",
      "recalling_firm": "Cepheid",
      "address_1": "904 E Caribbean Dr",
      "city": "Sunnyvale",
      "state": "CA",
      "postal_code": "94089-1189",
      "additional_info_contact": "Darwa Peterson\n408-242-7380",
      "reason_for_recall": "pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in \"invalid\" results or no result test  results.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On April 28, 2023, Cepheid issued a Important product recall notification to affected consignees via FedEx. In addition to informing consignees about the recall, Cepheid ask consignees to take the following action: \n\n2. If, upon following this guideline for proper use of the pipette you determine that your pipette fails to aspirate an\nadequate volume of liquid, repeat the steps using a new pipette.\n\n3. We ask that you acknowledge receipt of this Important Product Notice by responding via a web request from https://www.cepheid.com/streppipette (for US customer only) or by completing the enclosed Customer Response Form (email or Fax). In addition, replacement pipettes, if needed, can be requested via the above mentioned process.\nPlease complete this activity within 10 days, so we are assured you have received this important communication. The Customer Response Form can be emailed to CFQ@cepheid.com or faxed to +1 (408) 716-3143.\n\n4. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter.",
      "product_quantity": "89,958 kits ( 10 test per kit)",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.",
      "openfda": {
        "k_number": [
          "DEN140005",
          "K173398",
          "K260333",
          "K141173",
          "K201269",
          "K143651",
          "K141757",
          "K150868",
          "K183366",
          "K162274",
          "K141338",
          "K172126",
          "K172402",
          "K173653"
        ],
        "registration_number": [
          "1528450",
          "3004530258",
          "9610126",
          "3003018722",
          "3004141078",
          "3003795116",
          "1524213",
          "2243471",
          "2023365",
          "3012494290",
          "3012918440",
          "3005360469",
          "3016838963",
          "3019946577",
          "3009613136",
          "1221359",
          "3002773840"
        ],
        "fei_number": [
          "3004530258",
          "3005670738",
          "3003018722",
          "3004141078",
          "3003795116",
          "1000122536",
          "1524213",
          "2243471",
          "2023365",
          "3012494290",
          "3012918440",
          "3016838963",
          "3019946577",
          "3009613136",
          "1221359",
          "3002773840",
          "3002806559"
        ],
        "device_name": "Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2680",
        "device_class": "2"
      }
    }
  ]
}