FDA-Device2025-01-22Class II
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
DRG International, Inc.
Hazard
The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.
Sold states
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Affected count
10 units
Manufactured in
841 Mountain Ave, Springfield, NJ, United States
Products
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0921-2025Don't want to check this manually?
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