Polymer Technology Systems Recalls CardioChek Plus Analyzers Due to Battery Overheating Risk
Polymer Technology Systems is recalling 44,448 CardioChek Plus Professional Analyzers because a battery terminal defect can cause reverse contact and potential overheating.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall involving a risk of overheating, which aligns with the rubric criterion for 'Severe' (FDA Class II with significant injury/property-damage reports or structural defects).
Plain-English summary
Polymer Technology Systems, Inc. is recalling 44,448 units of the Henry Schein CardioChek Plus Professional Analyzer. The affected devices are new, boxed analyzers with carrying cases, identified by Reference Number 4060 HS and 570-0411. The recall covers all serial numbers shipped between November 1, 2016, and October 25, 2019, with UDI 00304040037713.
The recall is due to a small dimensional difference in the negative button terminal of one brand of batteries. If these batteries are inserted incorrectly, the terminals may make reverse contact, which creates a potential for overheating. The FDA has classified this as a Class II recall.
The products were distributed nationwide in the United States and to numerous foreign countries, including Australia, Canada, China, Germany, India, and the United Kingdom. Consumers and healthcare providers should stop using the affected analyzers and contact Polymer Technology Systems for instructions on how to return the devices.
The recalled product
- Product
- Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
- 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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