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VeraSens Voice
i-SENS, Inc. · Model 282442 · UDI-DI 00857513006193
1
510(k) clearances
432,413
Adverse events (116 deaths)
137
Recalls
170
Facilities
Description
VeraSens Voice Blood Glucose Meter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-06 | Trividia Health, Inc. | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended act |
| 2026-02-06 | Trividia Health, Inc. | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended act |
| 2026-02-06 | Trividia Health, Inc. | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended act |
| 2026-02-06 | Trividia Health, Inc. | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended act |
| 2025-10-07 | Trividia Health, Inc. | Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treat |
| 2025-01-30 | Telcare, LLC | Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The i |
| 2024-05-13 | Roche Diabetes Care, Inc. | The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an |
| 2023-05-19 | Ascensia Diabetes Care US, Inc. | Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters di |
| 2022-06-21 | Touch US Llc | Device was marketed without FDA 510(k) clearance or a PMA. |
| 2021-07-28 | Roche Diabetes Care, Inc. | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.