EPA (Environmental Protection Agency)
1 records
fda
13 records
FDA Device Recall: Revogene C. difficile, in vitro diagnostic assay intended for use with the Revog
2026-01-14
Class II — The affected lots show a decline in performance over time, which may lead to false-negative results.
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FDA Device Recall: Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid
2025-11-26
Class II — The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
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FDA Device Recall: Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid
2025-11-26
Class II — The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
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FDA Device Recall: Cardinal Health Clean Stool Transportation System-For the collection, transporta
2023-12-20
Class II — Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
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FDA Device Recall: Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preserv
2023-12-20
Class II — 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...
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FDA Device Recall: Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative dete
2023-02-01
Class II — 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
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FDA Recall: Meridian Bioscience Inc — Class II
20220406
The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-posi | Product: Revogene, For In Vitro Diagnostic use ...
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FDA Device Recall: Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clin
2022-04-06
Class II — 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.
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FDA Device Recall: Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transc
2021-05-19
Class II — Emergency Use Application (EUA) application withdrawn as false negative results reported
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FDA Device Recall: The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in se
2021-03-31
Class II — 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 ...
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FDA Device Recall: PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMI
2019-01-23
Class II — 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 specime...
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FDA Device Recall: PREMIER EHEC and PREMIER EHEC Bulk.
2017-01-25
Class II — Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
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FDA Device Recall: illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 inc
2014-07-09
Class II — Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
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