VITROS 5,1 FS CHEMISTRY SYSTEM - VARIOUS COMPONENTS (2015-03-11) — recall 53526
Health Canada — Medical Devices · Canada · 2015-04-14 · Type II
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Reported risk: Ortho Clinical Diagnostics (OCD) has identified an anomaly with Vitros System software version 3.1 and below. OCD determined that the software may not properly identify an expired calibration. Calibration status is monitored by the system software which is based upon the calibration interval and the date of the last calibration. OCD's investigation confirmed that if the anomaly occurs, a calibration may expire, but the system may not alert the operator and not flag results with a CE sample result code (i.e. calibration expired). The system may unexpectedly generate results even though it is configured to not report results when a calibration has expired.
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