RegWardenFDA facility compliance records
Company

PHADIA AB

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

Recalls by year

FDA actions on record by year2015: 1 recalls; 2017: 1 recalls; 2019: 2 recalls; 2023: 1 recalls1201520161201720182201920202021202212023202420252026
  • Recalls (5)

Registered facilities (4)

Recalls & enforcement

  • Class IIOngoing2023-05-24
    Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
  • Class IITerminated2019-07-09
    code 7-102 Liquid Sensor Error
  • Class IITerminated2019-05-10
    Potential for reporting low assay results
  • Class IITerminated2017-11-20
    We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tes…
  • Class IITerminated2015-12-28
    All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals ar…

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. “PHADIA AB — 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-9004441-phadia-ab/

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