# FDA recall Z-2070-2025

> **HemoCue AB** · Class II · device recall initiated 2025-05-12.

## 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.

## 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.

## Distribution

US Nationwide distribution in the state of AR.

## Key facts

- **Recall number:** Z-2070-2025
- **Recalling firm:** HemoCue AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-12
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Angelholm, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2070-2025

## Citation

> AI Analytics. FDA recall Z-2070-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2070-2025. Source: US FDA. Licensed CC0.

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