{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Webster",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87057",
      "recalling_firm": "Ansh Labs, LLC",
      "address_1": "445 W Medical Center Blvd",
      "address_2": "N/A",
      "postal_code": "77598-4217",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states of TX, MO, OK, MD, FL, NY, OR, GA, NC. OUS: None",
      "recall_number": "Z-0842-2021",
      "product_description": "AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.",
      "product_quantity": "327 kits (93 test per  kit)",
      "reason_for_recall": "Labeling update; To reduce the risk of false positive/false negative results the IFU for the adaptive immune response to SRS-CoV-2 testing is being updated  to remove Plasma as a \"sample type\" and to update the \"limitation\" section to include potential cross-reactivity with non-SARS-CoV2 strains.",
      "recall_initiation_date": "20201218",
      "center_classification_date": "20210111",
      "termination_date": "20220111",
      "report_date": "20210120",
      "code_info": "Lot #/Expiration Date: 040720/2021-10-06, 041620/2021-10-15, 041720/2021-10-18, 042420/2021-10-15, 042720-A/2021-10-26"
    }
  ]
}