RegWardenFDA facility compliance records
Company

Life Technologies Corporation

9 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2017: 1 recalls; 2018: 4 recalls; 2019: 1 recalls; 2020: 1 recalls; 2024: 1 recalls1’13’14’15’161’174’181’191’20’21’22’231’24’25’26
  • Recalls (9)

Registered facilities (9)

Recalls & enforcement

  • Class IIOngoing2024-02-07
    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 IITerminated2020-03-16
    Extended Expiration Date prior to clearance
  • Class IITerminated2019-06-11
    Component was not tested by the supplier for adventitious agents
  • Class IITerminated2018-08-24
    Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
  • Class IITerminated2018-05-10
    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, le…
  • Class IITerminated2018-02-08
    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 IITerminated2018-02-07
    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 IITerminated2017-12-04
    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 IITerminated2013-05-13
    Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Life Technologies Corporation — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9915045-life-technologies-corporation/

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