PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: July 9, 2025 Initiated: May 12, 2025 #Z-2070-2025

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.

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.

Details

Recalling Firm
HemoCue AB
Units Affected
4 Boxes
Distribution
US Nationwide distribution in the state of AR.
Location
Angelholm

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by HemoCue AB. Units affected: 4 Boxes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2025. Severity: Moderate. Recall number: Z-2070-2025.

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