6 results
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47ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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AUTION HYBRID AU-4050
FDA Recall
Terminated
·Arkray Factory USA, Inc.·Product code KQO·May 3, 2019
arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
FDA Recall
Terminated
·Arkray Factory USA, Inc.·Product code CGA·December 18, 2015
arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.
FDA Recall
Terminated
·Arkray Factory USA, Inc.·Product code CGA·December 18, 2015
arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
FDA Enforcement
Class I
·Terminated·Arkray Factory USA, Inc.·January 27, 2016
arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.
FDA Enforcement
Class I
·Terminated·Arkray Factory USA, Inc.·January 27, 2016
AUTION HYBRID AU-4050
FDA Enforcement
Class II
·Terminated·Arkray Factory USA, Inc.·June 26, 2019