Life Technologies Corporation
Grand Island, NY, US
LIFE TECHNOLOGIES CORPORATION appears in FDA device records in Grand Island, NY. FDA records list 11 510(k) clearances between and , 50 PMA records and 7 registered establishments. As of , FDA records show 24 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Life Technologies Corporation between 1995 and 2025. The busiest year on record is 1995, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 2 |
| 2001 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241806 | Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel | QOF | Substantially Equivalent | |
| K233453 | Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit | QQX | Substantially Equivalent | |
| K191030 | Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer | PCA | Substantially Equivalent | |
| K170299 | Ion PGM Dx System | PFF | Substantially Equivalent | |
| K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | OOI | Substantially Equivalent | |
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | NDS | Substantially Equivalent | |
| K103302 | STEMPRO MSC SFM | NDS | Substantially Equivalent | |
| K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | NDS | Substantially Equivalent | |
| DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | NDS | Unknown | |
| K953719 | HUMAN TUBAL FLUID | MFD | Substantially Equivalent | |
| K951835 | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE | MFD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007287152 | 3007287152 | LIFE TECHNOLOGIES CORPORATION | 5781 Van Allen Way, Carlsbad, CA 92008 US | 2026 | |
| 3009207631 | 3009207631 | LIFE TECHNOLOGIES CORPORATION | 2130 Woodward St, Austin, TX 78744 US | 2026 | |
| 3009976420 | 3009976420 | LIFE TECHNOLOGIES CORPORATION | 6055 Sunol Blvd, Pleasanton, CA 94566 US | 2026 | |
| 3011104381 | 3011104381 | LIFE TECHNOLOGIES CORPORATION | 180 Oyster Point Blvd, S San Fran, CA 94080 US | 2026 | |
| 3015529000 | 3015529000 | LIFE TECHNOLOGIES CORPORATION | 246 Goose Lane, Guilford, CT 06437 US | 2026 | |
| 1317268 | 1317268 | Life Technologies Corporation | 3175 STALEY ROAD, GRAND ISLAND, NY 14072 US | 2026 | |
| 3003335080 | 3003335080 | Life Technologies Corporation | 7335 Executive Way, FREDERICK, MD 21704 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GPRAntiserum, Cf, Q Fever
- MFDCannula, Intrauterine Insemination
- JJHClinical Sample Concentrator
- PCADna Genetic Analyzer
- LDYFixative, Formalin-Containing
- PPMGeneral Purpose Reagent
- PFFHigh Throughput Dna Sequence Analyzer
- NJTImmunohistochemistry Reagents And Kits
- KIQKit, Culture, Chromosome
- NDSMedia, Culture, Ex Vivo, Tissue And Cell
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- PZMNext Generation Sequencing Based Tumor Profiling Test
- PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- PFTReagents For Molecular Diagnostic Test Systems
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- MVUReagents, Specific, Analyte
- OOIReal Time Nucleic Acid Amplification System
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1426-2024 | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166 | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument | Class II | Open, Classified | |
| 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 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 | 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. | Class II | Terminated | |
| Z-2978-2020 | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, 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 | 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. | Class II | Terminated | |
| Z-1707-2020 | Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444 | Extended Expiration Date prior to clearance | Class II | Terminated | |
| Z-1706-2020 | Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441 | Extended Expiration Date prior to clearance | Class II | Terminated | |
| Z-1705-2020 | Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443 | Extended Expiration Date prior to clearance | Class II | Terminated | |
| Z-1704-2020 | Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442. | Extended Expiration Date prior to clearance | Class II | Terminated | |
| Z-0275-2020 | CTSTM Essential 8 Medium | Component was not tested by the supplier for adventitious agents | Class II | Terminated | |
| Z-0274-2020 | StemPro MSC SFM CTS" | Component was not tested by the supplier for adventitious agents | Class II | Terminated | |
| Z-0174-2019 | Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product | Class II | Terminated | |
| Z-0173-2019 | Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product | Class II | Terminated | |
| Z-0172-2019 | Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141 | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product | Class II | Terminated | |
| Z-0171-2019 | Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use | Leaky bottles due to a defect in the bottle cap compromising the sterility of the product | Class II | Terminated | |
| Z-2547-2018 | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium. | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media. | Class II | Terminated | |
| Z-2546-2018 | Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium. | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media. | Class II | Terminated | |
| Z-2545-2018 | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium. | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media. | Class II | Terminated | |
| Z-2544-2018 | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium. | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media. | Class II | Terminated | |
| Z-2543-2018 | GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium. | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media. | Class II | Terminated | |
| Z-2542-2018 | Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium. | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media. | Class II | Terminated | |
| Z-1480-2018 | Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test. | The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen. | Class II | Terminated | |
| Z-1388-2018 | Human Fetal Hemoglobin (HBF-1) FITC Conjugate | Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.e. false positives) | Class II | Terminated | |
| Z-1279-2018 | Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling. | The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens. | Class II | Terminated | |
| Z-2085-2013 | HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests. | Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA. | Class II | Terminated | |
| Z-0461-2012 | SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. | In vitro diagnostic reagent may be contaminated with a fungal contaminant. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain