Meridian Revogene SARS-CoV-2 Test Recalled Due to False Negative Results
Meridian Bioscience is recalling 376 Revogene SARS-CoV-2 test kits because the FDA withdrew the Emergency Use Application after false negative results were reported.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Severe (Score 4) because it involves a medical device with reported false negative results, which poses a significant risk of misdiagnosis and potential harm to patients, aligning with the rubric for significant injury or risk-of-harm products.
Plain-English summary
Meridian Bioscience Inc is recalling 376 kits of the Revogene SARS-CoV-2 assay (Catalog Number 410700). This in vitro diagnostic (IVD) test is used for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) to detect SARS-CoV-2 nucleic acid from nasopharyngeal swab specimens. The recall covers all lot numbers and the product was distributed nationwide.
The recall was initiated because the FDA withdrew the Emergency Use Application (EUA) for the device. The withdrawal was necessitated by the reporting of false negative results, which means the test failed to detect the virus in some cases.
Healthcare facilities and laboratories that purchased these kits should stop using them immediately. Users should contact Meridian Bioscience for instructions on how to return the product or obtain a refund. Individuals who received a negative result from this specific test kit should consult their healthcare provider to discuss the possibility of retesting.
The recalled product
- Product
- Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals susp
- Manufacturer
- Meridian Bioscience Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Meridian Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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