FDA (Devices) recall action 61910
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
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 VITROS 5,1 FS System Software versions 2.6.1 and below because the software may fail to verify quality assessments when reagent lots are switched.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System Software due to a defect that prevents proper quality verification when reagent lots are switched.
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System Software due to a defect that prevents proper quality assessment verification when reagent lots are switched.