ALINITY C CALCIUM2
Received Jul 7, 2026 · Event occurred Jun 24, 2026
Report 3005094123-2026-00329 · MDR key 25736122
Device
Generic name
Azo Dye, Calcium
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
04T87-30
Lot number
82017UD00
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED FALSE ELEVATED CALCIUM GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: REFERENCE RANGE FOR CALCIUM: 2.00¿2.70 MMOL/L. ON (B)(6) 2026: SAMPLE ID (B)(6), INITIAL RESULT WAS 4.001 ON SN: (B)(6) AND REPEAT RESULTS WERE 4.845 ON SN: (B)(6) AND 1.42 ON SN: (B)(6). ON (B)(6) 2026: SAMPLE ID (B)(6) INITIAL RESULT WAS 2.735 ON SN: (B)(6) AND REPEAT RESULTS WERE 4.148 ON SN: (B)(6) AND 2.444 ON SN: (B)(6). ON (B)(6) 2026: SAMPLE ID (B)(6), INITIAL RESULT WAS 3.357 ON SN: (B)(6) AND REPEAT RESULTS WERE 4.155 ON SN: (B)(6) AND 2.252 ON SN: (B)(6). ON (B)(6) 2026: SAMPLE ID (B)(6), INITIAL RESULT WAS 3.37 ON SN: (B)(6) AND REPEAT RESULTS WERE >6.0 ON SN: (B)(6) AND 2.419 ON SN: (B)(6). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.