Polymer Technology Systems, Inc.: 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.

Agency Publication Date: January 21, 2020

Affected Products

Product: PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00381932700016

Product: PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00381932702010

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

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040040539

Product: Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040037713

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84274

Status: Resolved

Manufacturer: Polymer Technology Systems, Inc.

Manufactured In: United States

Units Affected: 4 products (44,448 total; 44,448 total; 44,448; 44,448 total)

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Sources: FDA iRES · Raw API Response

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