FDA Device recall Z-2979-2020
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 P…
- FDA Device
- Class II
- terminated
- Published 2020-09-23
On 2020-09-23 the FDA classified a Class II recall of 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 P… by Life Technologies, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2979-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-06 |
| Published | 2020-09-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Life Technologies |
| Distribution | 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, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
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 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.
Identifiers
| code_info | Product SKU: Product Lot/Serial#: Release Date: 100093765 Version 1.2 (EUA) 28-APR-20 100087427 Versio…Product SKU: Product Lot/Serial#: Release Date: 100093765 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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2979-2020%22
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