The Recall Desk
HighFDA (Devices)·Z-2070-2025·Announced 2025-07-09

HemoCue Glucose Microcuvettes Recalled Due to Storage Degradation

HemoCue Glucose 201 Microcuvettes are being recalled because transit conditions outside recommended storage limits may have compromised device stability. Affected products may deliver incorrect or delayed blood glucose test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a recall of a diagnostic medical device—a risk-of-harm product where inaccurate test results could indirectly cause serious injury through incorrect medication decisions (e.g., wrong insulin dosing). No illnesses or injuries have been reported, fitting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

HemoCue Glucose 201 Microcuvettes are being recalled. These diagnostic microcuvettes are designed for use with the HemoCue Glucose 201 or DM Analyzer to measure blood glucose levels. The affected lot is 2501708, consisting of 4 boxes distributed through a McKesson shipment.

The microcuvettes experienced storage conditions outside recommended limits during transit. This exposure compromised the product's stability, quality, identity, potency, and purity. As a result, the products may not perform as intended and could deliver incorrect or delayed test results.

Facilities or individuals using lot 2501708 should verify their product inventory and contact HemoCue AB or their supplier if affected. Any reliance on test results from this lot should be reconsidered, though the recall notice does not specify methods to identify or confirm affected results.

The recalled product

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 Microcu
Manufacturer
HemoCue AB
Category
Medical Device — Diagnostic / Blood Glucose Testing
Hazard
  • incorrect-test-result
  • delayed-test-result
  • storage-degradation

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 (2)

  • UDI-DI: 07311091107060
  • Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category