Reported Sep 23, 2020 · Terminated
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the…
Life Technologies Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Life Technologies Corporation · 6055 Sunol Blvd · Pleasanton, CA · 94566-7853
Is this the product you have?
- 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 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
- Lot codes and dates
- Product SKUProduct Lot/Serial#:
- Release Date100093765 Version 1.2 (EUA) 28-APR-20 100087427 Version 2.2 (EUA) 11-MAY-20 100093771 Version 1.2 (CE-IVD) 28-APR-20 100094318 Version 2.2 (CE-IVD) 19-MAY-20 Applied Biosystems" COVID-19 Interpretive Software Version 1.2 was the first version of software developed in a dedicated CE-IVD Edition. Previous versions are shared with the FDA-EUA version of the device
- Amount recalled
- NA
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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