| 2025-12-05 |
Class II
|
Ongoing |
Z-1019-2026 |
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 |
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The affected lots show a decline in performance over time, which may lead to false-negative results. |
| 2025-10-07 |
Class II
|
Ongoing |
Z-0569-2026 |
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay |
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The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. |
| 2025-10-07 |
Class II
|
Ongoing |
Z-0568-2026 |
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay |
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The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. |
| 2023-10-19 |
Class II
|
Ongoing |
Z-0521-2024 |
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of s… |
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Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. |
| 2023-10-19 |
Class II
|
Ongoing |
Z-0520-2024 |
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimen… |
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Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated… |
| 2023-10-19 |
Class II
|
Ongoing |
Z-0519-2024 |
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing inte… |
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Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated… |
| 2022-12-15 |
Class II
|
Ongoing |
Z-1008-2023 |
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Num… |
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Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen con… |
| 2022-06-22 |
Class II
|
Ongoing |
Z-1479-2022 |
Revogene, Catalog no. 610210. IVD test instrument |
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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… |
| 2022-02-15 |
Class II
|
Ongoing |
Z-0836-2022 |
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Re… |
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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 in… |
| 2021-04-08 |
Class II
|
Terminated |
Z-1541-2021 |
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the… |
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Emergency Use Application (EUA) application withdrawn as false negative results reported |
| 2021-04-08 |
Class II
|
Terminated |
Z-1540-2021 |
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-P… |
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Emergency Use Application (EUA) application withdrawn as false negative results reported |
| 2021-02-08 |
Class II
|
Terminated |
Z-1299-2021 |
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in … |
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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 w… |