FDA-Device2016-01-27Class I
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.
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
11 boxes (25 foil packaged test strips per box)
Manufactured in
5182 W 76th St, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0631-2016Don't want to check this manually?
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