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Displaying 1 - 4 of 4 items.
VITROS® ECi Immunodiagnostic System - Troponin I Es Reagent Pack
Ortho Clinical Diagnostics (QuidelOrtho) became aware of an issue affecting VITROS® Immunodiagnostic products Troponin I Es Reagent Pack, lot 4800. Due to a manufacturing error, around 1% of reagent packs contain incorrect wells which will generate…
RecallHealth product recall | 2023-06-22
Vitros ECi Immunodiagnostic Intact PTH Reagent
Ortho received 166 world-wide complaints for Vitros iPTH reagent pack related to observations of lower-than-expected iPTH patient and quality control (QC) results with the affected lots listed above. Customers reported the negatively biased iPTH results…
RecallHealth product recall | 2022-12-02
Vitros Immunodiagnostic Products HIV Combo Reagent Pack
Scenario 1:
Ortho received a customer complaint for false negative results generated from Vitros HIV combo reagent pack, lot 0670, when testing a proficiency sample identified to be reactive for the presence of HIV-1 p24 antigen and absent of antibodies…
RecallHealth product recall | 2022-09-14
Vitros® Immunodiagnostic Products
Ortho Clinical Diagnostics has observed an increase in complaints, and confirmed observed imprecision, for 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.…
RecallHealth product recall | 2022-04-11