2 results
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34ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.
FDA Recall
Open, Classified
·Abbott Laboratories, Inc·Product code MZA·February 3, 2022
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
FDA Recall
Open, Classified
·Abbott Laboratories, Inc·Product code MZA·July 12, 2021