Corrective Actions
Root cause, immediate action, CAPA, assignee, evidence, approval, and closure.
Filters
open
1
Alanine Aminotransferase failed QC (L2)
Chemistry · Chem Analyzer A1
Root cause: Reagent lot change without recalibration
Immediate: Quarantined patient results, repeated QC after calibration verification.
CAPA: Update SOP to require recalibration on reagent lot change; retrain overnight shift.
Assignee: K. RiveraDue 9/29/2026
Evidence: QC re-run log, Calibration report, Reagent traceability
in progress
1
Hemoglobin failed QC (L1)
Hematology · Hema-Line H1
Root cause: Probe carryover after preventive maintenance
Immediate: Quarantined patient results, repeated QC after calibration verification.
CAPA: Update SOP to require recalibration on reagent lot change; retrain overnight shift.
Assignee: L. FischerDue 9/28/2026
Evidence: QC re-run log, Calibration report, Reagent traceability
pending approval
1
Hemoglobin failed QC (L2)
Hematology · Hema-Line H1
Root cause: Reagent lot change without recalibration
Immediate: Quarantined patient results, repeated QC after calibration verification.
CAPA: Update SOP to require recalibration on reagent lot change; retrain overnight shift.
Assignee: P. NakamuraDue 9/27/2026
Evidence: QC re-run log, Calibration report, Reagent traceability
closed
1
Platelets failed QC (L1)
Hematology · Hema-Line H1
Root cause: Probe carryover after preventive maintenance
Immediate: Quarantined patient results, repeated QC after calibration verification.
CAPA: Update SOP to require recalibration on reagent lot change; retrain overnight shift.
Assignee: S. AhmedDue 9/26/2026
Evidence: QC re-run log, Calibration report, Reagent traceability
Closed: Verified stable across two consecutive shifts.