Class 2 Device Recall CardioChek Professional Analyzer

• Date Initiated by Firm: December 02, 2019
• Create Date: January 21, 2020
• Recall Status: Terminated on July 06, 2020
• Recall Number: Z-0834-2020
• Recall Event ID: 84274
• 510(K)Number: K140068
• Product Classification: System, test, blood glucose, over the counter - Product Code NBW
• Product: Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
• Code Information: All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040040539
• Recalling Firm/ Manufacturer: Polymer Technology Systems, Inc.; 7736 Zionsville Rd; Indianapolis IN 46268-2175
• For Additional Information Contact: Teresa Florczak; 317-870-5610
• Manufacturer Reason for Recall: One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Correction notification letters dated 11/15/19 were sent to customers. Actions to be taken by the Customer/Distributor/User: 1. Immediately check your inventories and apply the sticker/labels as directed. If you are an end user: Please adhere one label to the outside of the battery door compartment of your analyzer and apply the other label to the analyzer user guide. If you are a distributor: Please remove the tape liner on the back of the large sticker leaving both small labels intact for the end user to apply. Apply the large sticker to the top panel of the analyzer box, and press firmly. 2. If you have further distributed this product, immediately identify the users and notify them at once of this product correction. Forward this notice, stickers, and response form to all customers/users who did, or who may have, received, this product. 3. Once you have taken the appropriate action, please fill out the attached response form and return it to PTS Diagnostics via the information below. It is important that you complete and return the response form, even if you do not have affected product on hand. 4. Please contact PTS for additional stickers and a PDF version of this letter and response form, if needed. Thank you for your prompt action, and we apologize for any inconvenience this issue may have caused you and your facility. If you have any questions, please contact Customer Service, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 319-870-5610 or 877-870-5610 (U.S. toll-free), or via email at response@ptsdiagnostics.com.
• Quantity in Commerce: 44,448
• Distribution: The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad, UAE.
• 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