FDAFDA · Food and drugs·Recall number Z-2070-2025
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.
Published July 9, 2025 · Recall initiated: May 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- HemoCue AB
- Distributor
- US Nationwide distribution in the state of AR.
- Lot
- UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.