Recall Z-2979-2020 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Life Technologies Corporation
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 health
| Date | Aug 6, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | On 08/06/2020, the firm sent an "Urgent: Medical Device Field Correction" notification to customers via email and a follow-up letter via FedEx informing them of two issues associated with COVID-19 interpretive software: 1) A small number of poorly extracted patient samples were called valid by the interpretive software, related to current MS2 assay analysis settings. This issue can potentially cause a weakly positive sample that is prepared by suboptimal extraction to be falsely called a valid negative sample, thereby constituting a False Negative. And 2) The MS2 assay, which detects the Inter |
| Quantity | NA |
| Distribution | US: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, NV, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. OUS: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana, B |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.