# FDA recall Z-2978-2020

> **Life Technologies Corporation** · Class II · device recall initiated 2020-08-06.

## Product

The 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

## 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.

## 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.

## Key facts

- **Recall number:** Z-2978-2020
- **Recalling firm:** Life Technologies Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-06
- **Report date:** 2020-09-23
- **Termination date:** 2022-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2978-2020

## Citation

> AI Analytics. FDA recall Z-2978-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2978-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*