Class 2 Device Recall PTS Panels CHOLHDLGLU Test Strips

• Date Initiated by Firm: March 15, 2016
• Create Date: December 26, 2019
• Recall Status: Terminated on June 05, 2020
• Recall Number: Z-0741-2020
• Recall Event ID: 84264
• 510(K)Number: K162282 K071507
• Product Classification: System, test, blood glucose, over the counter - Product Code NBW
• Product: PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
• Code Information: Lot Number I502, UDI 00381932412018
• Recalling Firm/ Manufacturer: Polymer Technology Systems, Inc.; 7736 Zionsville Rd; Indianapolis IN 46268-2175
• For Additional Information Contact: Karmen Mercer; 317-870-5610
• Manufacturer Reason for Recall: This lot of test strips is showing an under-recovery when tested against a reference method.
• FDA Determined Cause: Storage
• Action: Customer Notification Letters dated 3/15/16 was sent to customers. Distributors were instructed to do the following: We need your assistance to communicate this information to any customers to whom you have shipped this specific lot of product. As per Quality System Regulations, you must have full traceability of medical product to the end-user. Please advise your customers to complete the Customer Acknowledgement and Notification Form so that PTS Diagnostics can document that they have received the notification. Upon receipt of the acknowledgement, PTS Diagnostics will provide replacements for any product which has not been consumed. Customers with any of this product remaining in their possession must Immediately discontinue use and dispose of their remaining inventory of PTS Panels CHOL+HOL+GLU test strips, lot number 1502. No other lots of this product or other PTS Diagnostics products are impacted by this action. PTS Diagnostics will provide appropriate replacement product for any product properly identified on the attached Customer Acknowledgement and Confirmation Form. Please immediately identify the number of remaining PTS Panels CHOL+HDL+GLU test strip vials you currently have remaining in inventory of lot 1502 on the attached form. We will supply you with replacement product for any unused inventory you have of this product and lot. Please return your completed form to PTS Diagnostics via fax at +1-317-870-5608 or via email at customerservice@ptsdiagnostics.com. Customers were instructed to do the following: Customers with any of this product remaining in their possession must Immediately discontinue use and dispose of their remaining inventory of PTS Panels CHOL+HOL+GLU test strips, lot number 1502. No other lots of this product or other PTS Diagnostics products are impacted by this action. PTS Diagnostics will provide appropriate replacement product for any product properly identified on the attached Customer Acknowledgement and Confir
• Quantity in Commerce: 6467
• Distribution: The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.
• 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.; 510(K)s with Product Code = NBW and Original Applicant = Polymer Technology Systems, Inc. d/b/a PTS Diagnostics