We have launched a voluntary medical device notification after finding that some of the Philips and BioTel Care® Connected Blood Glucose Meter may experience swelling. The swelling may occur from use of non-Philips or BioTel chargers, storing the meter improperly, or due to the age of the device. The swelling can affect the device’s performance.

The following products are affected: Philips Connected Blood Glucose Meter and the BioTel Care® Connected Blood Glucose Meter.

The cause of the issue has been identified. Battery replacements are available, and a new firmware update will be made available on your device to help its performance.

Less than 1% of devices have been affected by this issue.

To know if your device has been affected, please use the Meter Replacement Check tool.

The Meter Replacement Check tool will walk you through the steps to follow if your device has been affected. The tool will let us know if you need further assistance or a replacement. If you have any questions, please contact us at (888) 666-4530 (U.S.) or 1 (978) 610-4688 (International), Monday-Friday 9:00 AM to 9:00 PM, Eastern Time, excluding major holidays.

If your meter is working normally, you can keep using it. If you experience any of these issues, stop using your meter and contact us:

1. The meter looks damaged or cracked.
2. The meter is swollen.
3. The meter is too hot to hold.
4. The meter won’t hold a charge.
5. You don’t have the Philips or BioTel charger.

If any of these happen, use the Meter Replacement Check tool to notify us of the issue.

One of our team members will receive your information and contact you for further support, if needed. If you need immediate assistance, contact Philips Customer Service at (888) 666-4530 (US) or (1) (978) 610-4688 (International), Monday-Friday from 9:00 AM to 9:00 PM Eastern Time, excluding major holidays.

The serial number is located on the label on the back of the meter. Serial numbers will begin with “TF” or “TG”.

If your meter has been affected by this issue, we will send you a replacement and an instruction guide. If you have any questions, please contact Philips Customer Service at (888) 666-4530 (US) or (1) (978) 610-4688 (International), Monday-Friday from 9:00 AM to 9:00 PM Eastern Time, excluding major holidays.

Yes! Our Connected Blood Glucose Meters will continue to be provided for individual use.

If you need any further information or support concerning this issue, please contact Philips Customer Service at (888) 666-4530 (US) or (1) (978) 610-4688 (International), available Monday – Friday from 9 AM – 9 PM Eastern Time, excluding major holidays.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

1. Complete and submit the report Online.
2. Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).