HemoCue AB: Medical Device Recall in 2025 - (Recall #: Z-2070-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 12, 2025

Date Posted: July 9, 2025

Recall Number: Z-2070-2025

Event ID: 97025

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.

Status: Ongoing

Product Quantity: 4 Boxes

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of AR.

Voluntary or Mandated:

Voluntary: Firm initiated