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Arkray Factory USA, Inc. recalls arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quanti
Recalled January 27, 2016 · FDA recall Z-0630-2016 · Arkray Factory USA
Hazard
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL. · FDA Class I
Units
88 boxes (25 foil packaged test strips per box)
Sold at
Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Description
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
Product
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.
Manufacturer(s)
Arkray Factory USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →