FDA Device recall Z-1334-2016
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black
- FDA Device
- Class I
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class I recall of Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black by Dexcom, citing customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1334-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-02-23 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Dexcom |
| Distribution | US |
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.
Reason
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Identifiers
| code_info | Receiver Kit Number: STK-GL-001 STK-RX-001 STR-GL-001 STK-GL-PNK STK-RX-PNK STR-GL-PNK STK-GL-BLU STK-RX-BLU S…Receiver Kit Number: STK-GL-001 STK-RX-001 STR-GL-001 STK-GL-PNK STK-RX-PNK STR-GL-PNK STK-GL-BLU STK-RX-BLU STR-GL-BLU Lot Number: 2009655 5022776 5022797 5032813 5032814 5032815 5039607 5045819 5045820 5045821 5045822 5045823 5045824 5045825 5045826 5045827 5046248 5046249 5046250 5046251 5046252 5046254 5046344 5046345 5046346 5046347 5046348 5046349 5046350 5046351 5046352 5046353 5046354 5046355 5046356 5046464 5046465 5046466 5046467 5046468 5046469 5047822 5047823 5047824 5047825 5047826 5047827 5047828 5047829 5047830 5049500 5049501 5049502 5049503 5049504 5049505 5049506 5049507 5049508 5049509 5049510 5049511 5049512 5049513 5049514 5049515 5053609 5053610 5053611 5053612 5053613 5053614 5053615 5053616 5053617 5053618 5053619 5053620 5053621 5053622 5053623 5053624 5055634 5055635 5055636 5055637 5060693 5067169 5067170 5067171 5067172 5067173 5067174 5067175 5067176 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1334-2016%22
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