{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Richmond",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90336",
      "recalling_firm": "Mckesson Medical-Surgical Inc. Corporate Office",
      "address_1": "9954 Maryland Drive",
      "address_2": "Deep Run Iii Ste. 4000",
      "postal_code": "23233",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide",
      "recall_number": "Z-1598-2022",
      "product_description": "Strep test:  a.  McKesson Medical-Surgical\tMcKesson\tRapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003.   b.  QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274.   c.  Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999.   d.  In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345.   e.  (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests, Model Number: 92001",
      "product_quantity": "a. 214 kits  b. 1cs  c. 53 kits d. 4 bx  e. 1 KT",
      "reason_for_recall": "Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.",
      "recall_initiation_date": "20220525",
      "center_classification_date": "20220825",
      "report_date": "20220831",
      "code_info": "GTIN:  a. 00612479240100; 00612479202733.   b. 30014613202745.   c.  00612479202726; 612479240094.   d.  30014613003458.   e.  10815845020031, 00815845020034.",
      "more_code_info": ""
    }
  ]
}