Home / Recalls / Arkray Factory USA, Inc. / Z-0630-2016

Z-0630-2016 Class I Terminated

Recalled by Arkray Factory USA, Inc. — Minneapolis, MN

Recall Details

Product Type: Devices
Report Date: January 27, 2016
Initiation Date: December 18, 2015
Termination Date: January 4, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 88 boxes (25 foil packaged test strips per box)

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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

Code Information

Lot Number EA4M78