Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers of the G5 Mobile Receivers with software version SW10617 and software revision 4.0.1.048 Receiver Part Number/Reciver Kit Number/GUDID registered GTINS/ Receiver Kit Type: Dexcom G5 Mobile Receiver, MT22179 (BLK) Rev 013 and Rev 014 Receiver (mg/dL), Black STK-GF-001/ 10386270000238 - Starter Kit STK-RF-001/20386270000235 - Retail Starter Kit STR-GF-001/30386270000232 - Replacement Receiver Kit STK-GF-IUO/NA - Investigational Use STK-MC-001/00386270000606 - Medicare Starter Kit Dexcom G5 Mobile Receiver, MT22719 (PNK) Rev 012 and 013, Receiver (mg/dL), Pink STK-GF-PNK/ 30386270000263 - Starter Kit STK-RF-PNK/10386270000269 - Retail Starter Kit STR-GF-PNK/20386270000266 - Replacement Receiver Kit Dexcom G5 Mobile Receiver, MT22719 (BLU) Rev 012 and 013, Receiver (mg/dL), Blue STK-GF-BLU/ 30386270000270 - Starter Kit STK-RF-BLU/10386270000276 - Retail Starter Kit STR-GF-BLU/20386270000273 - Replacement Receiver Kit
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Dexcom Inc
- Reason for Recall:
- It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
Product Codes/Lot Numbers:
All serial numbers of the G5 Mobile Receivers with software version SW10617 and software revision 4.0.1.048 Receiver Part Number/Reciver Kit Number/GUDID registered GTINS/ Receiver Kit Type: Dexcom G5 Mobile Receiver, MT22179 (BLK) Rev 013 and Rev 014 Receiver (mg/dL), Black STK-GF-001/ 10386270000238 - Starter Kit STK-RF-001/20386270000235 - Retail Starter Kit STR-GF-001/30386270000232 - Replacement Receiver Kit STK-GF-IUO/NA - Investigational Use STK-MC-001/00386270000606 - Medicare Starter Kit Dexcom G5 Mobile Receiver, MT22719 (PNK) Rev 012 and 013, Receiver (mg/dL), Pink STK-GF-PNK/ 30386270000263 - Starter Kit STK-RF-PNK/10386270000269 - Retail Starter Kit STR-GF-PNK/20386270000266 - Replacement Receiver Kit Dexcom G5 Mobile Receiver, MT22719 (BLU) Rev 012 and 013, Receiver (mg/dL), Blue STK-GF-BLU/ 30386270000270 - Starter Kit STK-RF-BLU/10386270000276 - Retail Starter Kit STR-GF-BLU/20386270000273 - Replacement Receiver Kit
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0929-2020
Related Recalls
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