Dexcom G4, G5 & G6 Continuous Glucose Monitoring System (2020-05-29)
- Starting date:
- May 29, 2020
- Posting date:
- June 12, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73319
Last updated: 2020-06-12
Affected Products
- Dexcom G4 Continuous Glucose Monitoring System - Sensor
- Dexcom G4 Platinum Sensor Kit
- Dexcom G5 Mobile / G4 Platinum Sensor Kit
- Dexcom G6 Sensor
Reason
Dexcom recently became aware that Hydroxyurea, an anti-neoplastic drug used primarily in chemotherapy, falsely elevates glucose readings on Dexcom CGM Systems. This may result in failure to treat hypoglycemia from missed low sensor glucose values and alerts or by causing other errors in diabetes management decisions.
Affected products
A. Dexcom G4 Continuous Glucose Monitoring System - Sensor
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- STS-GL-001
- STS-GL-004
Companies
- Manufacturer
-
DEXCOM, INC.
6340 SEQUENCE DRIVE
SAN DIEGO
92121-4356
California
UNITED STATES
B. Dexcom G4 Platinum Sensor Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- STK-CL-100
- STS-CL-100
- STS-GL-005
- STS-GL-006
- STS-GL-007
- STS-GL-010
Companies
- Manufacturer
-
DEXCOM, INC.
6340 SEQUENCE DRIVE
SAN DIEGO
92121-4356
California
UNITED STATES
C. Dexcom G5 Mobile / G4 Platinum Sensor Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- STS-GF-001
- STS-GF-004
- STS-GF-007
- STS-GF-010
Companies
- Manufacturer
-
DEXCOM, INC.
6340 SEQUENCE DRIVE
SAN DIEGO
92121-4356
California
UNITED STATES
D. Dexcom G6 Sensor
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- STS-GS-008
- STS-GS-015
Companies
- Manufacturer
-
DEXCOM, INC.
6340 SEQUENCE DRIVE
SAN DIEGO
92121-4356
California
UNITED STATES