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U.S. Department of Health and Human Services

Class 1 Device Recall SPOTCHEM II Glucose test strips

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 Class 1 Device Recall SPOTCHEM II Glucose test stripssee related information
Date Initiated by FirmDecember 18, 2015
Date PostedJanuary 15, 2016
Recall Status1 Terminated 3 on January 04, 2017
Recall NumberZ-0630-2016
Recall Event ID 72860
510(K)NumberK041427 
Product Classification Glucose oxidase, glucose - Product Code CGA
Productarkray 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.
Code Information Lot Number EA4M78
Recalling Firm/
Manufacturer		 Arkray Factory USA, Inc.
5182 W 76th St
Minneapolis MN 55439-2900
For Additional Information ContactCustomer 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
ActionThe 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 Commerce88 boxes (25 foil packaged test strips per box)
DistributionDistributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CGA
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