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Lower risk Medical device recall · FDA · Published August 6, 2020

Life Technologies Recalls COVID-19 Test Software: Risk of False Results

Life Technologies recalls specific versions of their COVID-19 test software due to potential false negatives and false positives, which could lead to inaccurate test results and increased retesting.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2979-2020Medical deviceLife Technologies ›
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Contact the company

Recalling firmLife Technologies Corporation6055 Sunol Blvd · Pleasanton, CA 94566-7853
✎ GovInfoNow plain-language explainer

Life Technologies is recalling certain versions of their COVID-19 test software that may produce false negative or false positive results. This could lead to inaccurate test outcomes and unnecessary retesting for users. Read more at govinfonow.com/recall/64516-life-technologies-recalls-covid-19-test-software-risk-of-false.

Source Summary by GovInfoNow · govinfonow.com/recall/64516-life-technologies-recalls-covid-19-test-software-risk-of-false · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2979-2020

Cite this page

“Life Technologies Recalls COVID-19 Test Software: Risk of False Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64516-life-technologies-recalls-covid-19-test-software-risk-of-false. Based on FDA recall #Z-2979-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2979-2020%22&limit=1).

The Food and Drug Administration announced on Aug. 6, 2020, that Life Technologies Corporation is recalling The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 due to software issues that may cause invalid or inconclusive tests and false positive results.

How to tell if you have it

  • Brand: Life Technologies
  • Product: The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2
  • Used with: QuantStudio Real-Time PCR platforms
  • SKU 100093765, Version 1.2 (EUA), Release Date 28-APR-20
  • SKU 100087427, Version 2.2 (EUA), Release Date 11-MAY-20
  • SKU 100093771, Version 1.2 (CE-IVD), Release Date 28-APR-20
  • SKU 100094318, Version 2.2 (CE-IVD), Release Date 19-MAY-20

The hazard

The hazard involves COVID-19 Interpretive Software issues that may cause the risk of invalid or inconclusive tests or false negatives, potentially increasing the retesting burden on customers. The software issues may also lead to false positive results due to improper vortexing.

Context

GovInfoNow's records show Life Technologies Corporation has 6 other recalls on record since Dec. 4, 2017. Other recent recalls of similar products include Vivoo Protein Test Recall (Nov. 22, 2025), LH One Step Ovulation Test Device Recall (Nov. 22, 2025), and Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025).

How to tell if you have this one

Check for product SKUs 100093765 (v1.2 EUA), 100087427 (v2.2 EUA), 100093771 (v1.2 CE-IVD), or 100094318 (v2.2 CE-IVD) on the software packaging. The software is used with QuantStudio Real-Time PCR platforms for COVID-19 testing.

  • Brand
    Life Technologies
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    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 numberProduct, codes & lots
Z-2978-2020The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, 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 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.
Z-2979-2020The 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 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.
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on your packaging to see if it matches the recalled SKUs listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 44 states and Puerto Rico, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: not listedWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Aug 6, 202012. FDA classified it Class II: Sep 17, 202023. Published in FDA’s Enforcement Report: Sep 23, 202034. FDA terminated the recall: May 5, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the software immediately?

No, the recall does not require immediate discontinuation; users should check their software version and update if necessary.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2979-2020 (August 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2979-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA