FDA (Devices) recall action 83322
The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ortho Clinical Diagnostics is recalling 30 VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Ortho Clinical Diagnostics is recalling 2,531 VITROS 5600 Integrated Systems due to a software anomaly that may cause unsuccessful calibration.
Ortho Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Ortho Clinical Diagnostics is recalling two VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Ortho Clinical Diagnostics is recalling 825 VITROS 4600 Chemistry Systems worldwide due to a software anomaly that may cause unsuccessful calibrations.
Ortho Clinical Diagnostics is recalling 89 VITROS 5600 clinical chemistry analyzers worldwide due to a software anomaly that may cause unsuccessful calibrations.
Ortho Clinical Diagnostics is recalling 30 VITROS 250AT Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Ortho Clinical Diagnostics is recalling 55 VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
Ortho Clinical Diagnostics is recalling nine VITROS 4600 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Ortho Clinical Diagnostics is recalling 30 VITROS 350 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.