Ortho-Clinical Diagnostics FDA Recalls

5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
VITROS Performance Verifier IClass IIFeb 27, 2024The issue was mismatched diluent lots assembled into VITRO C	The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. T	Class IIDevices	Feb 27, 2024
VITROS Performance Verifier IIClass IIFeb 27, 2024The issue was mismatched diluent lots assembled into VITRO C	The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. T	Class IIDevices	Feb 27, 2024
VITROS Immunodiagnostic Products Troponin I ES Reagent PackClass IIJun 5, 2023Reagent packs could potentially contain incorrect wells, whi	Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false	Class IIDevices	Jun 5, 2023
VITROS Immunodiagnostic Products Troponin I ES CalibratorsClass IIJun 5, 2023Reagent packs could potentially contain incorrect wells, whi	Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false	Class IIDevices	Jun 5, 2023
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Class IIMay 8, 2023Potential to cause biased results in the upper end of the re	Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of	Class IIDevices	May 8, 2023