Recall Z-0835-2020 ยท NBW System, Test, Blood Glucose, Over The Counter
Polymer Technology Systems, Inc.
Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
| Date | Dec 2, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction notification letters dated 11/15/19 were sent to customers. Actions to be taken by the Customer/Distributor/User: 1. Immediately check your inventories and apply the sticker/labels as directed. If you are an end user: Please adhere one label to the outside of the battery door compartment of your analyzer and apply the other label to the analyzer user guide. If you are a distributor: Please remove the tape liner on the back of the large sticker leaving both small labels intact for the end user to apply. Apply the large sticker to the top panel of the ana |
| Quantity | 44,448 total |
| 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, L |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140068 | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM Polymer Technology Systems, Inc., May 22, 2015 |