Starting from 1 January 2022, the summary includes some safety alerts related to glucose meters and test strips not listed under MDACS reported by the trade, other regulatory jurisdictions as well as the World Health Organization. It only serves as a reference and should not be considered as exhaustive and up-to-date information. Please contact manufacturer or local supplier for details.
| Posting Date | Description of Product | Source of Information * |
|---|---|---|
| 20 May 2024 | Macherey Nagel Gmbh & Co. Kg Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique | FDA |
| 22 Feb 2024 | Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication | FDA |
| 09 Jan 2024 | Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error | FDA |
| 08 Jan 2024 | Insulet Corporation Omnipod 5 App | FDA |
| 11 Oct 2023 | Roche Diabetes Care Accu‑Chek Solo system | MHRA |
| 11 Oct 2023 | Roche Diabetes Care Accu‑Chek Solo system | MHRA |
| 15 Aug 2023 | CamDiab Ltd CamAPS FX app version 1.4 (172) and all previous versions | MHRA |
| 02 Aug 2023 | Abbott Diabetes Care FreeStyle LibreLink app for iOS, version 2.10 | MHRA |
| 24 Jul 2023 | Ascensia Diabetes Care US, Inc. Contour next GEN Blood Glucose Monitoring System [Model No.: 7917; Lot No. DM01T033P; Mutiple serial numbers] | FDA |
| 07 Jun 2023 | Roche Diabetes Care GmbH Accu-Chek Solo diabetes manager included in Accu-Chek Solo system kits and Accu-Chek Solo replacement kits: DM Guide Solo mol, DM Aviva Solo mol, Accu-Chek Solo System G mol AU/en, Accu-Chek Solo system A mol AU/en, Accu-Chek Guide Solo Repl mol and Accu-Chek Aviva Solo Repl mol [Reference numbers: 08873976001, 07835604001, 09524223001, 07864051001, 08872007001 and 07859481001; Software versions: 20.33 and 20.55] | TGA |
| 12 Apr 2023 | Abbott FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System [Product Models: all Reader serial numbers; Distribution Dates: Beginning November 2017 – February 2023] | FDA |
| 06 Apr 2023 | Abbott Readers in the FreeStyle Libre product family - FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems [all Reader serial numbers] | FDA |
| 14 Feb 2023 | Abbott FreeStyle LibreLink App for Android and FreeStyle Libre 3 App for Android (all versions) | MHRA |
| 07 Feb 2023 | Abbott Diabetes Care FreeStyle Libre 2 Sensors [Lot KTP005061] | MHRA |
| 03 Aug 2022 | Touch US Llc. etouchus, model no. ETM-G01. Noninvasive Blood glucose meter. | FDA |
* FDA = Food and Drug Administration, United States of America;
MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada;
TGA = Therapeutic Goods Administration, Australia;
HPRA = Health Products Regulatory Authority, Ireland;
HSA = Health Sciences Authority, Singapore
Starting from 1 January 2022, safety alerts related to glucose meters and test strips not listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.