Drugs & medicalClass II

Meridian Bioscience Inc recalls Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal…

Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.

Read the official notice →
Date
2023-12-20
Country
United States
Brand
Meridian Bioscience
Product
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal…
Classification
Class II
Units
Nationwide Foreign: Italy
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Meridian Bioscience recalls

  1. 2026-01-14
  2. US
    Drugs & medicalClass II

    Meridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

    The affected lots show a decline in performance over time, which may lead to false-negative results.

    FDA · DeviceMeridian Bioscience IncUS Nationwide distribution and the OUS country of Italy.Official notice →
  3. 2025-11-26
  4. US
    Drugs & medicalClass II

    Meridian Bioscience Inc recalls Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

    The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

    FDA · DeviceMeridian Bioscience IncUS Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN,…Official notice →
  5. 2023-12-20
  6. US
    Drugs & medicalClass II

    Meridian Bioscience Inc recalls Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens…

    Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.

    FDA · DeviceMeridian Bioscience IncNationwide Foreign: ItalyOfficial notice →
  7. 2023-02-01
  8. US
    Drugs & medicalClass II

    Meridian Bioscience Inc recalls Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700

    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

    FDA · DeviceMeridian Bioscience IncUS Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN,…Official notice →
  9. 2022-08-03
  10. US
    Drugs & medicalClass II

    Meridian Bioscience Inc recalls Revogene, Catalog no. 610210. IVD test instrument

    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…

    FDA · DeviceMeridian Bioscience IncWorldwide distribution - US Nationwide and the countries of Australia, Chile,…Official notice →
  11. 2022-04-06
  12. US
    Drugs & medicalClass II

    Meridian Bioscience Inc recalls Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog…

    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.

    FDA · DeviceMeridian Bioscience IncWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →
All 7 Meridian Bioscience recalls →

Other drugs & medical recalls in the United States

  1. 2023-12-20
  2. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

    Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL…Official notice →
  3. US
    Drugs & medicalClass II

    Medtronic Inc. recalls Medtronic SynchroMed, Model A10

    The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus,…

    FDA · DeviceMedtronic Inc.Foreign DistributionOfficial notice →
  4. US
    Drugs & medicalClass II

    Meridian Bioscience Inc recalls Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens…

    Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.

    FDA · DeviceMeridian Bioscience IncNationwide Foreign: ItalyOfficial notice →
  5. US
    Drugs & medicalClass II

    Riverpoint Medical, LLC recalls Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF…

    Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of…

    FDA · DeviceRiverpoint Medical, LLCU.S. Nationwide distribution in the state of CA.Official notice →
  6. US
    Drugs & medicalClass II

    Bebig Isotopentechnik Gmbh recalls SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System

    Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.

    FDA · DeviceBebig Isotopentechnik GmbhUS: MD OUS: GermanyOfficial notice →
  7. US
    Drugs & medicalClass II

    BioReference Health, LLC recalls The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate…

    Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.

    FDA · DeviceBioReference Health, LLCUS Nationwide distribution.Official notice →
See all drugs & medical recalls →