ALINITY C CARBON DIOXIDE REAGENT KIT
Received Jul 13, 2026 · Event occurred Jun 17, 2026
Report 3002809144-2026-00180 · MDR key 25796676
Device
Generic name
Enzymatic, Carbon-dioxide
Manufacturer
Abbott GmbhCatalog number
07P72-20
Lot number
69531UQ01
Product problems
- Low Test Results
Patient
NA · Unknown
- 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY DECREASED CARBON DIOXIDE (CO2) RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: INITIAL=14.0 MMOL/L /REPEATED=23.0 MMOL/L ON (B)(6) 2026 SID (B)(6): 60YRS OLD MALE: INITIAL=17 MMOL/L /REPEATED=22 MMOL/L LABORATORY REFERENCE RANGE FOR CO2=22 TO 30 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.