FDAMay 12, 2025device
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 availa...
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Ongoing
Brands named
hemocue abhemocue
UPCs
07311091107060
Recall history
No related federal recalls on record for this brand yet.
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