Life Technologies Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 7
- Inspections
- 14
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1426-2024 | Class II | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD i | February 7, 2024 |
| Z-2979-2020 | Class II | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 | August 6, 2020 |
| Z-2978-2020 | Class II | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 750 | August 6, 2020 |
| Z-1707-2020 | Class II | Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cel | March 16, 2020 |
| Z-1705-2020 | Class II | Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell l | March 16, 2020 |
| Z-1704-2020 | Class II | Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lu | March 16, 2020 |
| Z-1706-2020 | Class II | Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell | March 16, 2020 |
| Z-0274-2020 | Class II | StemPro¿ MSC SFM CTS" | June 11, 2019 |
| Z-0275-2020 | Class II | CTSTM Essential 8 Medium | June 11, 2019 |
| Z-1480-2018 | Class II | Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). | February 8, 2018 |
| Z-1388-2018 | Class II | Human Fetal Hemoglobin (HBF-1) FITC Conjugate | February 7, 2018 |
| Z-1279-2018 | Class II | Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)1019030200607 | December 4, 2017 |
| Z-2085-2013 | Class II | HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HS | May 13, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241806 | Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel | January 8, 2025 |
| K233453 | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit | July 10, 2024 |
| K191030 | Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer | February 21, 2020 |
| K170299 | Ion PGM Dx System | June 22, 2017 |
| K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | March 8, 2013 |
| K103302 | STEMPRO MSC SFM | February 18, 2011 |
| K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | May 20, 2010 |