The Recall Desk

FDA (Devices) recall action 86204

Life Technologies Corporation recalled 2 products on 2020-09-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-09-23
Critical
0
Units
—

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    Product
    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
    Category
    Distribution
    45 states
  • HighFDA (Devices)··2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    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
    Category
    Distribution
    45 states