FDA-Device2022-05-25Class II
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Ortho-Clinical Diagnostics, Inc
Hazard
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
Sold states
Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore Spain Sweden United Kingdom
Affected count
2502 total: 2154 US; 348 OUS
Manufactured in
1001 Us Highway 202, N/A, Raritan, NJ, United States
Products
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1112-2022Don't want to check this manually?
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