Polymer Technology Systems, Inc. PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
Brand
Polymer Technology Systems, Inc.
Lot Codes / Batch Numbers
All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00381932700016
Products Sold
All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00381932700016
Polymer Technology Systems, Inc. is recalling PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Refe due to One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can cr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026