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U.S. Department of Health and Human Services

Class 1 Device Recall SPOTCHEM II Basic Panel test strips

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 Class 1 Device Recall SPOTCHEM II Basic Panel test strips see related information
Recall Date January 15, 2016
Recall Status1 Open
Recall Number Z-0631-2016
Recall Event ID 72860
510(K)Number K053401 
Product Classification Glucose oxidase, glucose - Product Code CGA
Product 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.
Code Information Lot Number PN5C26
Recalling Firm/
Manufacturer
Arkray Factory USA, Inc.
5182 W 76th St
Minneapolis MN 55439-2900
For Additional Information Contact Customer Service
877-538-8872 Ext. 3243
Manufacturer 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.
FDA Determined
Cause 2
Component design/selection
Action The firm sent an Urgent Medical Device Recall letter to customers beginning 12/18/2015. The letter identified affected product, stated the reason for recall and asked for unused product to be returned. For instructions on returning unused product contact Lesty Jaranilla 1-877-538-8872 x3243.
Quantity in Commerce 11 boxes (25 foil packaged test strips per box)
Distribution Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CGA and Original Applicant = ARKRAY, INC.
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