Arkray Factory USA, Inc. recalls arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitati…

Recall date

December 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0630-2016

FDA classification

Class I

Brand / firm

Arkray Factory USA, Inc.

Sold / distributed

Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.