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Meridian Bioscience Inc Recall 87556

Description: 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 suspected of COVID-19

Meridian Bioscience Inc Recall 87556 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-1540-2021
Event ID87556
Event DescriptionRevogene 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 suspected of COVID-19
Product TypeDevices
DistributionNationwide
Quantity376 kits of the Revogene SARS-CoV-2 assay
Recall ReasonEmergency Use Application (EUA) application withdrawn as false negative results reported
Device Classification20210519
Device Code InfoAll lot numbers
Center Classification Date20210507
Recall Initiation Date20210408
Recalling FirmMeridian Bioscience Inc
Initial Notification Letter
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