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Gmate® SMART Blood Glucose Monitoring System
PHILOSYS Co., Ltd · Model PG-101 · UDI-DI 08809301166017
1
510(k) clearances
7,604
Adverse events (14 deaths)
89
Recalls
132
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-12 | HemoCue AB | Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not ha |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2024-03-01 | Alere San Diego, Inc. | There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may |
| 2022-08-16 | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. | Incorrect instructions for use were packaged into the final product. |
| 2022-06-24 | Alere San Diego, Inc. | Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations gre |
| 2020-08-28 | Siemens Healthcare Diagnostics Inc | Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hyp |
| 2019-09-18 | Medline Industries Inc | Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. |
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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.