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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk diagnostic test where software errors could lead to false negative or positive results, posing a significant risk of harm to patient care, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Life Technologies Corporation is recalling the TaqPath RT-PCR COVID-19 Kit, which includes Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2. The kit is used with QuantStudio Real-Time PCR platforms to detect SARS-CoV-2 RNA in respiratory specimens.
The recall is due to software issues that may cause invalid or inconclusive tests, false negative results, and false positive results due to improper vortexing. These issues may increase the retesting burden on customers.
The affected products were distributed in the United States and various international locations. Users should contact Life Technologies Corporation for further instructions on how to proceed with the recall.
The recalled product
- 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
- Manufacturer
- Life Technologies Corporation
- Category
- Medical Device — Diagnostic Test
Distribution
Part of a larger recall action
This product is one of 2 recalled by Life Technologies Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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