HemoCue Glucose Microcuvettes (HemoCue) – Stability Concern (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.
Brand
HemoCue AB Kuvettgatan 1 Angelholm Sweden
Lot Codes / Batch Numbers
UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
Products Sold
UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
HemoCue AB Kuvettgatan 1 Angelholm Sweden is recalling The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Anal due to Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. Th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026