PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
Check against the official notice below — it lists the full affected range.
Polymer Technology Systems, Inc. is recalling 44,448 refurbished CardioChek Plus Professional Analyzer units (Reference Number 2702) distributed nationwide in the US and internationally. The devices contain batteries with a small dimensional difference in the negative button terminal that, when inserted incorrectly, can cause the battery terminals to make reverse contact. This reverse contact poses a potential for overheating. The affected devices have serial numbers shipped between November 1, 2016 and October 25, 2019.
The recall affects units distributed to numerous countries including Canada, Mexico, Australia, China, and throughout Europe, the Middle East, and Asia. The source document does not specify a remedy or any actions consumers should take in response to this recall.
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: 00381932702010
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.