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U.S. Department of Health and Human Services

Class 2 Device Recall PTS Panels CHOLGLU Test Strips

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  Class 2 Device Recall PTS Panels CHOLGLU Test Strips see related information
Date Initiated by Firm March 14, 2018
Create Date April 28, 2018
Recall Status1 Terminated 3 on September 13, 2018
Recall Number Z-1543-2018
Recall Event ID 79778
510(K)Number K041750  
Product Classification System, test, blood glucose, over the counter - Product Code NBW
Product PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
Code Information Lot # A705  UDI (01)00381931765016(17)180813(10)A705
Recalling Firm/
Manufacturer		 Polymer Technology Systems, Inc.
7736 Zionsville Rd
Indianapolis IN 46268-2175
For Additional Information Contact Heidi Hancock Strunk
317-870-5610
Manufacturer Reason
for Recall		 Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
FDA Determined
Cause 2		 Under Investigation by firm
Action Letters will be sent to each ship-to address, as well as each bill-to address via UPS with signature requirement. Customers will be instructed to immediately quarantine and destroy any materials remaining from these two lots.
Distribution OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
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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