ALINITY C CALCIUM2
Received Jun 12, 2026 · Event occurred Jun 5, 2026
Report 3005094123-2026-00282 · MDR key 25486142
Device
Generic name
Azo Dye, Calcium
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
04T87-20
Lot number
82015UD00
Product problems
- High Test Results
Patient
37 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM RESULTS GENERATED FROM ALINITY C PROCESSING MODULE. THE CUSTOMER PROVIDED THE FOLLOWING DATA WHICH OCCURRED ON (B)(6) 2026: THE CALCIUM RESULT ON SN: (B)(6) WAS 3.77 MMOL/L. THE CALCIUM RESULT ON SN: (B)(6) WAS 4.12 MMOL/L. THE CALCIUM RESULT ON SN: (B)(6) WAS 2.96 MMOL/L. THE CALCIUM RESULT ON SN: (B)(6) WAS 2.94 MMOL/L. THE CALCIUM RESULT ON SN: (B)(6) WAS 2.41 MMOL/L. THE CUSTOMER REPORTED OUT THE 2.41 RESULT. CUSTOMER NORMAL RANGE IS 2.20-2.60 MMOL/L. PATIENT INFORMATION: 37-YEAR-OLD FEMALE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.