RegWardenFDA facility compliance records
Company

MERIDIAN BIOSCIENCE, INC.

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

Recalls by year

FDA actions on record by year2014: 1 recalls; 2016: 1 recalls; 2018: 1 recalls; 2021: 2 recalls; 2022: 3 recalls; 2023: 1 recalls; 2025: 2 recalls1’14’151’16’171’18’19’202’213’221’23’242’25’26
  • Recalls (11)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-12-05
    The affected lots show a decline in performance over time, which may lead to false-negative results.
  • Class IIOngoing2025-10-07
    The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
  • Class IIOngoing2023-10-19
    Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
  • Class IIOngoing2022-12-15
    Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
  • Class IIOngoing2022-06-22
    When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury …
  • Class IIOngoing2022-02-15
    The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
  • Class IITerminated2021-04-08
    Emergency Use Application (EUA) application withdrawn as false negative results reported
  • Class IITerminated2021-02-08
    Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may pr…
  • Class IITerminated2018-12-17
    An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.
  • Class IITerminated2016-11-08
    Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
  • Class IITerminated2014-04-22
    Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.

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. “MERIDIAN BIOSCIENCE, INC. — 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-1524213-meridian-bioscience-inc/

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