PTS Diagnostics CardioChek Plus Analyzer Recalled for Battery Overheating Risk
Polymer Technology Systems is recalling 44,448 CardioChek Plus Professional Analyzers because a battery terminal defect can cause overheating if batteries are inserted incorrectly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (overheating) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Polymer Technology Systems, Inc. is recalling 44,448 units of the PTS Diagnostics CardioChek Plus Professional Analyzer. The recalled units are new, boxed analyzers with carrying cases, Reference Number 2700. The recall covers all serial numbers shipped between November 1, 2016, and October 25, 2019. The products were distributed nationwide in the United States and to numerous foreign countries, including Australia, Canada, China, and the United Kingdom.
The recall was initiated because one brand of batteries used with the device has a small dimensional difference in the negative button terminal. When these specific batteries are inserted incorrectly, the terminals can make reverse contact. This reverse contact creates a potential for the battery terminals to overheat.
Consumers who have purchased or received this device should stop using it immediately. They should contact Polymer Technology Systems, Inc. for instructions on how to return the device or obtain a replacement. The agency has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
- Manufacturer
- Polymer Technology Systems, Inc.
- Affected units
- 44,448
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Polymer Technology Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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