RegWardenFDA facility compliance records
Facility

THERMO ELECTRON LED GmbH

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2018: 1 inspections; 2019: 2 recalls; 2020: 1 recalls; 2021: 1 recalls; 2025: 1 inspections1’12’13’14’15’16’171’182’191’201’21’22’23’241’25’26
  • Recalls (5)
  • Inspections (2)

Devices registered here (1)

  • Accessory, Assisted Reproduction, Exempt
    Product code PUB (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.6120

Recalls & enforcement

  • Class IITerminated2021-02-01
    Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual si…
  • Class IITerminated2020-04-29
    Product was not irradiated; therefore, they are not sterile and do not meet product specification.
  • Class IITerminated2019-07-18
    Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
  • Class IITerminated2019-04-02
    Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
  • Class IITerminated2012-11-29
    Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.

FDA inspections (2)

  • NAI2025-03-20
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2018-04-26
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “THERMO ELECTRON LED GmbH (FEI 3005737891) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005737891-thermo-electron-led-gmbh/

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