PTS Diagnostics CardioChek Plus Professional Analyzer recalled over fire hazard

Recall date

December 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Polymer Technology Systems, Inc. recalls PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700

Recall number

Z-0832-2020

FDA classification

Class II

Brand / firm

Polymer Technology Systems, Inc.

Sold / distributed

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, Le…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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