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.
This recall is currently active, issued July 2, 2025. It was issued by Hemocue Ab Kuvettgatan 1 Angelholm Sweden.
- Recall Initiated
- May 12, 2025
- Posted
- July 2, 2025
- Recall Number
- Z-2070-2025
- Quantity
- 4 Boxes
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
Root Cause
Storage
Action Taken
On 5/14/2025 field notices were emailed to customers who were asked to do the following: 1) Ensure that the affected product at customer site has been destroyed according to local regulations. 2) Complete and return the Field Notice Verification Form. If you have any questions regarding this Field Notice, please send an e-mail to cuvettes@hemocue.com