FDA-Device2018-04-18Class III
VITROS Immunodiagnostic Products TSH Reagent Pack
Clinical Diagnostic Systems
Hazard
VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
Sold states
Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
Affected count
Lot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)
Manufactured in
601 Lee Rd Ny, Rochester, NY, United States
Products
VITROS Immunodiagnostic Products TSH Reagent Pack
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2018Don't want to check this manually?
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