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U.S. Department of Health and Human Services

Class 2 Device Recall PTS Panels(R) Glucose Test Strips

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 Class 2 Recall
PTS Panels(R) Glucose Test Strips
see related information
Date Posted May 25, 2013
Recall Status1 Terminated on April 16, 2014
Recall Number Z-1403-2013
Recall Event ID 65067
Premarket Notification
510(K) Number
K013068 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
Code Information U1117
Recalling Firm/
Manufacturer
Polymer Technology Systems, Inc.
7736 Zionsville Rd
Indianapolis, Indiana 46268-2175
For Additional Information Contact Renee Nasser
317-870-5610
Manufacturer Reason
for Recall
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Polymer Technology Systems sent a Field Correction Action letters dated April 4, 2013 to distributors and customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use and dispose of remaining inventory of recalled product. Customers were asked to acknowledge and confirm recall directions were follwed by fax to 1-317-870-5608.
Quantity in Commerce 7048 total, 3499 in USA
Distribution Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.
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 = NBW and Original Applicant = POLYMER TECHNOLOGY SYSTEMS, INC.
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