Z-0834-2020Class II

Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036

Name: Z-0834-2020 Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Creator: Polymer Technology Systems, Inc.
Published: 2019-12-02
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2019-12-02 / Terminated / root cause: design

FDA source

Polymer Technology Systems, Inc. began a recall of Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 on 2019-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0834-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-02
Posted: 2020-01-21
Terminated: 2020-07-06
Recalling firm: Polymer Technology Systems
Product: Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Product code: NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag: design
FDA 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 [email protected].
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.
Product codes and lots: All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040040539

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0834-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0832-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-21
Z-0833-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-21
Z-0834-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-21
Z-0835-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-21

Product code NBW

K140068Class IICardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. / cleared 2015-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)