Diabetes HbA1c tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 148 units of its Diabetes HbA1c Test because the product was distributed without premarket approval or clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a premarket clearance shortfall with no stated product defect, consequence or reported harm.
Plain-English summary
The Diabetes HbA1c Test from Get Tested International AB is being recalled. The product is identified by EAN 7340221707191 and SKU A-HbA1c, and the recall covers all lots.
The reason given in the enforcement record is distribution without premarket approval or clearance.
The record lists a quantity of 148 units, distributed nationwide in the United States. The FDA has classified the action as Class II.
The record describes a regulatory clearance issue rather than a specific product defect, and states no injuries. Customers should follow the firm's instructions.
The recalled product
- Product
- MENTHOL AND ZINC OXIDE (MENTHOL AND ZINC OXIDE)
- Brand
- MENTHOL AND ZINC OXIDE
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Medical Device — Diagnostic test
- Affected units
- 2,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: A482305
UPCs (1)
- 0616784127514
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Blossom Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · Blossom Pharmaceuticals
See all →- ModerateClotrimazole cream, 1 ounce size, recalled over good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateWound hydrogel recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateDynashield Skin Protectant, 16 ounce size, recalled over manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateWeCare zinc oxide ointment recalled over good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateLanashield Skin Barrier recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
Same hazard · unapproved device
See all →- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateOne Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13