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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 Stripssee related information
Date Initiated by FirmApril 04, 2013
Date PostedMay 25, 2013
Recall Status1 Terminated 3 on April 16, 2014
Recall NumberZ-1403-2013
Recall Event ID 65067
510(K)NumberK013068 
Product Classification System, test, blood glucose, over the counter - Product Code NBW
ProductPTS 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 ContactRenee 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
ActionPolymer 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 Commerce7048 total, 3499 in USA
DistributionWorldwide 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 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 = NBW
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