Recall Z-1270-2025 ยท NBW System, Test, Blood Glucose, Over The Counter
Telcare, LLC
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
| Date | Mar 5, 2025 (initiated Jan 30, 2025) |
| Status | Open, Classified |
| Reason | Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatm |
| Root cause | Software design |
| Action | On January 30, 2025, an IMPORTANT Safety Notification message was pushed out to display on all meter devices. IMPORTANT Safety Notification: https://www.gobio.com/bgm - information on proper battery use. Mensaje importante sobre batera. What you should do: If you have a Philips or BioTel charger and your meter is working normally, you can keep using it. If you experience any of these issues, stop using your meter and contact Philips Customer Service at (888) 666-4530 (US) or (1) (978) 610-4688 (International): 1. The meter looks damaged or cracked. 2. The meter is swollen. 3. The meter is too |
| Quantity | 34,764 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110571 | TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE Telcare, Inc., Jul 28, 2011 |