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 diagnostic medical device where software errors can lead to false negative or false positive results for a serious infectious disease. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as incorrect diagnostic results can lead to inappropriate medical management, though no specific injuries or deaths are reported in the source text.
Plain-English summary
Life Technologies Corporation is recalling the TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments. The recall involves specific software versions (1.2 and 2.2) for both FDA-EUA and CE-IVD editions, released between April and May 2020.
The recall is issued because the software may cause invalid or inconclusive tests, false negatives, or false positive results due to improper vortexing. These issues may increase the retesting burden on customers. The product is a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory and bronchoalveolar lavage specimens.
The affected products were distributed in the United States and numerous international locations. Users should contact Life Technologies Corporation for further instructions regarding the recall and potential replacement or refund.
The recalled product
- 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
- Manufacturer
- Life Technologies Corporation
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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