PTS Diagnostics CardioChek Plus Analyzer Recalled for Battery Overheating Risk
Polymer Technology Systems is recalling 44,448 refurbished CardioChek Plus Professional Analyzers because a battery terminal defect may 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, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Polymer Technology Systems, Inc. is recalling 44,448 units of the PTS Diagnostics CardioChek Plus Professional Analyzer. These are refurbished analyzers shipped without a box or carrying case, with Reference Number 2702. The affected units were distributed nationwide in the United States and to numerous foreign countries, including Australia, Canada, China, Germany, and India.
The recall is due to a small dimensional difference in the negative button terminal of one brand of batteries. When these batteries are inserted incorrectly, the terminals can make reverse contact. This reverse contact creates a potential for the device to overheat.
The affected units have serial numbers shipped between November 1, 2016, and October 25, 2019, and carry the UDI 00381932702010. Users should check their device serial numbers against this range. If the device is affected, users should stop using it and contact Polymer Technology Systems for instructions on how to proceed.
The recalled product
- Product
- PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
- 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.
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