5 results
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47ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code OZN·December 5, 2025
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JGS·May 13, 2021
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code LRO·April 28, 2025