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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:214236

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.

Official recall number

Z-2070-2025

Evidence summary

Product code
CGA
Recall status
Open, Classified
Event initiated
May 12, 2025
Root cause
Storage
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2070-2025

Field note

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