Ortho-Clinical Diagnostics
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Ortho-Clinical Diagnostics and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-04-03FDA-DeviceClass IIVITROS Performance Verifier II
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
- 2024-04-03FDA-DeviceClass IIVITROS Performance Verifier I
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
- 2023-08-16FDA-DeviceClass IIVITROS Immunodiagnostic Products Troponin I ES Calibrators
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
- 2023-08-16FDA-DeviceClass IIVITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
- 2023-07-19FDA-DeviceClass IIVITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.
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