Life Technologies Corporation recalls The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments…

Recall date

August 6, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2978-2020

FDA classification

Class II

Brand / firm

Life Technologies Corporation

Sold / distributed

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, B…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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