Alinity 07P5520Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740135447), received between Aug 20, 2019 and Aug 1, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED GLUCOSE RESULTS GENERATED FROM AN ALINITY C PROCESSING MODULE FOR A FEMALE PATIENT WHO WAS IN THE ICU. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6)WAS ORIGINALLY RUN ON (B)(6)2023 AT 0630 FOR A COMPLETE METABOLIC PANEL. LATER THAT DAY AT APPROXIMATELY 2130 THERE WAS A REQUEST TO ADD A BASIC METABOLIC PANEL. THE RESULTS WERE QUESTIONED ON 20 JULY, SO THE SAMPLE WAS REPEATED ON THE SAME ANALYZER (SN: (B)(6)) AND ALSO REPEATED ON ANOTHER ALINITY C PROCESSING MODULE (SN: (B)(6)) GLUCOSE RESULTS: INITIAL GLUCOSE RESULT ON 18 JULY WAS 53, REPEATED LATER THAT DAY THE RESULT WAS 224, REPEATED ON THE SAME ANALYZER ON 20 JULY WAS 220, REPEATED ON ANOTHER ANALYZER WAS 209. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437675 ↗
• MalfunctionJul 22, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED GLUCOSE RESULTS ON ONE PATIENT GENERATED ON THE ALINITY C PROCESSING MODULE. THE RESULTS PROVIDED WERE: INITIAL = 13MMOL/L (234.23MG/DL) / RETESTED = 12MMOL/L (216.22MG/DL); THE NEXT DAY, SAME PATIENT, NEW DRAW AT (B)(6) = ABOUT 5 MMOL/L (90.09MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211544 ↗
• MalfunctionAug 20, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED GLUCOSE RESULT GENERATED ON THE ALINITY C ANALYZER ON ONE (B)(6) FEMALE PATIENT. RESULTS PROVIDED: SID (B)(6), (B)(6) 2019 = 28.557 / 367.804 / ANOTHER ALINITY = 365.545 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8910060 ↗