2 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
FDA Recall
Terminated
·MedtestDx, Inc.·Product code JJY·May 15, 2015
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
FDA Enforcement
Class II
·Terminated·MedtestDx, Inc.·September 23, 2015