HemoCue AB: Device Recall

Recall #Z-2070-2025 · 05/12/2025

Class II: Risk

Recall Details

Recall Number: Z-2070-2025
Classification: Class II
Product Type: Device
Recalling Firm: HemoCue AB
Status: Ongoing
Date Initiated: 05/12/2025
Location: Angelholm, Sweden
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4 Boxes

Reason for Recall

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 Description

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.

Distribution Pattern

US Nationwide distribution in the state of AR.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.