Alinity 07P5530Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740135454), received between May 27, 2021 and Feb 21, 2025 — 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.

• MalfunctionFeb 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C GLUCOSE RESULT GENERATED BY THE ALINITY C PROCESSING MODULE FOR A PATIENT WITH ACUTE KIDNEY FAILURE. THE SAMPLE GENERATED ERROR 1039 (UNABLE TO CALCULATE RESULT. ABSORBANCE EXCEEDED OPTICAL LIMITS). THE LAB TECH THEN PERFORMED AN AUTOMATIC DILUTION WHICH GENERATED A RESULT OF 1,867 MG/DL. THIS RESULT WAS RELEASED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN AS IT WAS INCONSISTENT WITH THE RESULTS FROM THE POINT-OF-CARE DEVICE. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 70 TO 109 MG/DL. SID (B)(6): ON (B)(6)2025 @20:53 PM INITIAL RESULT = NO RESULT (EXCEPTION ERROR 1039), REPEAT #1 (UNDILUTED) = NO RESULT (EXCEPTION ERROR 1039), REPEAT #2 (UNDILUTED) = NO RESULT (EXCEPTION ERROR 1039), REPEAT #3 AUTOMATIC DILUTION (1:5) RESULT = 1,867 MG/DL, REPEAT #5 (UNDILUTED) = NO RESULT (EXCEPTION ERROR 1039), REPEAT #6 (UNDILUTED) = NO RESULT (EXCEPTION ERROR 1039), REPEAT #7 MANUAL DILUTION = NO RESULT (EXCEPTION ERROR 1039). GLUCOSE RESULTS BEFORE AND AFTER: ON (B)(6) 2025 @16:40 PM RESULT = 96 MG/DL, ON (B)(6) 2025 @03:13 AM RESULT = 93 MG/DL. GLUCOSE RESULTS FROM POINT-OF-CARE: 97 MG/DL, 101 MG/DL, 100 MG/DL. THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431204 ↗
• MalfunctionAug 22, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY C GLUCOSE RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT WITH DIABETES. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = < 5 MG/DL A RAPID BLOOD GLUCOSE TEST WAS PERFORMED ON THE PATIENT AND THE GLUCOSE RESULT OBTAINED WAS 240 MG/DL THE SAMPLE WAS REPEATED ON TWO OTHER INSTRUMENTS PRESENT IN THE LABORATORY: INSTRUMENT AC07153 REPEATED IN DUPLICATE AND GENERATED A RESULT OF < 5 MG/DL BOTH TIMES. INSTRUMENT (B)(6) REPEATED IN DUPLICATE ON CONCENTRATED AND DILUTED SAMPLE: RESULT OF UNDILUTED SAMPLE = < 5 MG/DL. RESULT OF DILUTED SAMPLE = < 25 MG/DL. THE CUSTOMER PERFORMED TESTING ON A SECOND SAMPLE FROM THE DIABETIC PATIENT: SAMPLE TUBE WITHOUT GEL SID (B)(6) RESULT = 50 MG/DL (RESULT BEING QUESTIONED) SAMPLE TUBE WITH GEL SID (B)(6) RESULT = 150 MG/DL (RESULT CONSIDERED IN LINE WITH PATIENT HISTORY) THE MEASURING INTERVAL OF THE ALINITY C GLUCOSE ASSAY SERUM/PLASMA APPLICATION IS 5 TO 800 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042293 ↗
• MalfunctionMay 27, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINICY C GLUCOSE RESULTS FOR ONE PATIENT. THE INITIAL RESULT WAS >800 MG/DL, REPEATED WITH 1:5 DILUTION AND THE RESULT WAS 315 MG/DL; THE INITIAL SAMPLE WAS REPEATED AND THE RESULT WAS >800 MG/DL, REPEATED WITH 1:5 DILUTION AND THE RESULT WAS 845 MG/DL. THE CUSTOMER IS QUESTIONING THE 1:5 DILUTION RESULT OF 315 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895114 ↗