Recall Z-2978-2020— Life Technologies Corporation
Class II · Terminated
Class II FDA medical device recall by Life Technologies Corporation, initiated 2020-08-06, terminated 2022-05-05. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Life Technologies Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-06
- Terminated
- 2022-05-05
- Firm location
- Pleasanton, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.