The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1334-2016·Announced 2016-04-20

Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

Dexcom Inc is recalling G4 PLATINUM Receivers because they may fail to provide intended audible alarms or alerts to users.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert."

Plain-English summary

Dexcom Inc is recalling the Dexcom G4 PLATINUM Receiver, which is intended to detect trends and track glucose patterns in persons with diabetes. The recall involves 131,768 units distributed worldwide, including the United States, Canada, and numerous other countries.

The recall is being issued because customers may not receive an intended audible alarm or alert if they are relying on hearing the alarm or alert. This defect could prevent users from being notified of glucose trends or patterns as intended.

Consumers with affected receivers should check their device against the specific part numbers and lot numbers listed in the official recall notice. Users should contact Dexcom Inc for instructions on how to resolve the issue.

The recalled product

Product
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Manufacturer
Dexcom Inc
Category
Medical Device — Glucose Monitoring
Hazard
Affected units
131,768

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Dexcom Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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