FDA-Device2016-01-27Class I
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.
Arkray Factory USA, Inc.
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.
Sold states
Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Affected count
88 boxes (25 foil packaged test strips per box)
Manufactured in
5182 W 76th St, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0630-2016Don't want to check this manually?
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