Class II — HemoCue AB
| Recalling firm | HemoCue AB |
|---|---|
| Registered facility | HEMOCUE AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result. |
| Product | The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial. |
| Quantity | 4 Boxes |
| Distribution | US Nationwide distribution in the state of AR. |
| Initiated | 2025-05-12 |
| Classified | 2025-07-02 |
| Recall number | Z-2070-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — HemoCue AB (Z-2070-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97025/
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