FDA Medical Device Recalls (openFDA)
Polymer Technology Systems, Inc.: Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
- Recall number
- Z-0835-2020
- Recalling firm
- Polymer Technology Systems, Inc.
- Product
- Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
- Status
- Terminated
- Initiated
- 2019-12-02
- Posted
- not on file
- Terminated
- 2020-07-06
- Reason
- 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.
- Root 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
- 44,448 total
- 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.
- Lot, serial or model codes
- All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040037713
- 510(k) numbers
- ["K140068"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3015525148
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28