3 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Quanta System Sterile Optical Laser Fiber, reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code MVU·November 23, 2009
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016