Alinity 07P7230Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740121600), received between Nov 1, 2019 and Nov 21, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED HAVING ISSUES WITH THE QUALITY CONTROL (QC) WITH THE CARBON DIOXIDE (CO2) REAGENT ON THE ALINITY ANALYZER. THE CUSTOMER STATED THEY REPLACED THE KIT AND THE QC WAS OK. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9353944 ↗
• MalfunctionNov 20, 2019Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE CUSTOMER REPORTED THE CARBON DIOXIDE (CO2) CONTROLS HAVE BEEN GOING UP DURING THE DAY. THE CUSTOMER HAD BEEN INSTRUCTED TO RUN THE CONTROLS EVERY 2 HOURS BUT WAS STILL EXPERIENCING THE ISSUE. THE CUSTOMER LOADED A NEW CO2 REAGENT ON THE ALINITY ANALYZER AND THE INTERNAL QUALITY CONTROLS WERE OK. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9350050 ↗
• MalfunctionNov 18, 2019Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE CUSTOMER REPORTED THE QUALITY CONTROL RESULTS WERE SHIFTED HIGH AND HAD A POSITIVE BIAS WITH THE ALINITY C CARBON DIOXIDE (CO2) REAGENT ON ALINITY INSTRUMENT WHEN COMPARED TO THE ARCHITECT C4000. THE CUSTOMER STATED THEY HAD RECEIVED THE PRODUCT RECALL LETTER AND HAVE SINCE OBTAINED SMALLER KITS. NO FURTHER ISSUES HAVE BEEN REPORTED AND THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9335046 ↗
• MalfunctionNov 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  ABBOTT R&D REPORTED THAT UNDER CERTAIN SITUATIONS, THE ALINITY C PROCESSING MODULES REAGENT CAROUSEL MOVEMENT CAN CAUSE CARBON DIOXIDE (CO2) CONTROL RESULTS TO DRIFT UP OVER TIME AND GO OUT OF RANGE. THERE WERE NO PATIENTS INVOLVED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9271416 ↗
• MalfunctionNov 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ABBOTT LABORATORIES HAS IDENTIFIED AN ISSUE WITH THE ALINITY C CO2 REAGENT DURING INTERNAL STUDIES. IT WAS DETERMINED THAT UNDER CERTAIN CONDITIONS, THE RATE AT WHICH ATMOSPHERIC CO2 IS DISSOLVED INTO THE REAGENT MAY ACCELERATE AND HAS THE POTENTIAL TO GENERATE INCORRECT RESULTS. THERE HAS BEEN NO REPORTED IMPACT TO PATIENT MANAGEMENT AS A RESULT OF THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 9268256 ↗