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…

Read the official notice →
Date
2022-08-03
Country
United States
Brand
Meridian Bioscience
Product
Revogene, Catalog no. 610210. IVD test instrument
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of Australia, Chile,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. US
    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.

    FDA · DeviceMeridian Bioscience IncNationwide Foreign: ItalyOfficial notice →
  8. 2023-02-01
  9. 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 →
  10. 2022-04-06
  11. 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. 2022-08-10
  2. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA Inc recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis…

    Failed Dissolution Specifications: below specification limits for dissolution.

    FDA · DrugTeva Pharmaceuticals USA IncNationwide in the USA and Puerto RicoOfficial notice →
  3. US
    Drugs & medicalClass II

    Tolmar, Inc. recalls Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC…

    Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time

    FDA · DrugTolmar, Inc.distributed to 1 consignee in KY.Official notice →
  4. 2022-08-03
  5. US
    Drugs & medicalClass II

    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

    Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

    FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)US Nationwide distribution in the states of Indiana and CA.Official notice →
  6. US
    Drugs & medicalClass II

    Stryker Instruments recalls Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

    There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical…

    FDA · DeviceStryker InstrumentsWorldwide distribution - US Nationwide distribution in the states of Arizona,…Official notice →
  7. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - SPT recalls Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number…

    Kits contain leaking bottles of isopropyl alcohol

    FDA · DeviceMEDLINE INDUSTRIES, LP - SPTUS Nationwide distribution.Official notice →
  8. US
    Drugs & medicalClass II

    SIGHT DIAGNOSTICS LTD recalls Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

    The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may…

    FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide distribution - US Nationwide distribution in the states of Alabama,…Official notice →
See all drugs & medical recalls →