The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19… — Class II medical device recall Z-2979-2020
Terminated recall by Life Technologies Corporation, reported 2020-09-23, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negat
| Recall number | Z-2979-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Life Technologies Corporation, Pleasanton, CA, United States |
| Recall initiated | 2020-08-06 |
| Classified | 2020-09-17 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2022-05-05 |
| Distributed | 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 |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BH, BR, CA, CH, DE, DZ, EE, ES, FR, GB, GR, HU, ID, IE, IL, IN, IT, KE, KW, LB, NZ, OM, PH, PL, PT, QA, RO, SA, SE, VN, ZA |
| Reason classes | software |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2979-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.