{
  "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": "Pleasanton",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86204",
      "recalling_firm": "Life Technologies Corporation",
      "address_1": "6055 Sunol Blvd",
      "address_2": "N/A",
      "postal_code": "94566-7853",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, NV, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.    OUS: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana, Brazil, Cameroon, Canada, Cypress, Estonia, France, Georgia, Germany, Greece, Guadeloupe, Hungary, India, Indonesia, Ireland, Israel, Italy, Kenya, Kuwait, Lebanon, Mozambique, Namibia, New Zealand, Oman, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, United Republic of Tanzania, and Vietnam.",
      "recall_number": "Z-2979-2020",
      "product_description": "The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software",
      "product_quantity": "NA",
      "reason_for_recall": "COVID-19 Interpretive Software issues that may cause:  1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers.  2) false positive results due to improper vortexing.",
      "recall_initiation_date": "20200806",
      "center_classification_date": "20200917",
      "termination_date": "20220505",
      "report_date": "20200923",
      "code_info": "Product SKU:  Product Lot/Serial#:  Release Date:   100093765  Version 1.2 (EUA)          28-APR-20   100087427  Version 2.2 (EUA)          11-MAY-20   100093771  Version 1.2 (CE-IVD)  28-APR-20   100094318  Version 2.2 (CE-IVD)  19-MAY-20     Applied Biosystems\" COVID-19 Interpretive Software Version 1.2 was the first version of software developed in a dedicated CE-IVD Edition.   Previous versions are shared with the FDA-EUA version of the device."
    }
  ]
}