Home / Recalls / Arkray Factory USA, Inc. / Z-0631-2016

Z-0631-2016 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: 11 boxes (25 foil packaged test strips per box)

Product Description

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.

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 PN5C26