FDADecember 18, 2015device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

arkray factoryarkray

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear