PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
Check against the official notice below — it lists the full affected range.
Polymer Technology Systems, Inc. is recalling 44,448 units of the PTS Diagnostics CardioChek Plus Professional Analyzer (Reference Number 2700) distributed nationwide in the U.S. and to numerous countries worldwide. The recall was initiated because certain batteries have a small dimensional difference in the negative button terminal that can allow reverse contact if inserted incorrectly, which may cause the batteries to overheat.
The affected devices include all units with serial numbers shipped between November 1, 2016 and October 25, 2019. The source document does not specify a remedy or instructions for consumers who have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South A Quantity: 44,448 total Lot/code info: All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00381932700016
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.