FDA-Device2023-05-31Class II
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
Ortho-Clinical Diagnostics, Inc.
Hazard
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Sold states
US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil Bermuda HM12 Canada L3R 4G5 Chile China Colombia Denmark France France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden The Netherlands United Kingdom
Affected count
23751
Manufactured in
1001 Us Highway 202, N/A, Raritan, NJ, United States
Products
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1628-2023Don't want to check this manually?
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