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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 Device Recall PTS Panels(R) Glucose Test Strips see related information
Date Initiated by Firm April 04, 2013
Date Posted May 25, 2013
Recall Status1 Terminated 3 on April 16, 2014
Recall Number Z-1403-2013
Recall Event ID 65067
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 IN 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		 Under Investigation by 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 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) Database 510(K)s with Product Code = NBW and Original Applicant = POLYMER TECHNOLOGY SYSTEMS, INC.
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