Alinity 07P6630Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380740121587), received between Sep 3, 2020 and Jan 15, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS WHEN COMPARED TO SIEMENS, BECKMAN, AND ATELLICA. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6) (36 YEAR OLD MALE): INITIAL RESULT = 49.16 NG/ML, SIEMENS RESULT = 25.12 NG/ML, ADDITIONAL DATA WAS PROVIDED BY THE CUSTOMER FOR SAMPLES THAT WERE SCREENED FOR MACROPROLACTIN WITH PEG: SID (B)(6) (50 YEAR OLD MALE): ATELLICA RESULT = 68.10, ALINITY RESULT = 95.36, PEG ATELLICA = 66.88, PEG ALINITY = 95.56, SID (B)(6) (45 YEAR OLD MALE): ATELLICA RESULT = 29.24, ALINITY RESULT = 182.53, PEG ATELLICA = 14.50, PEG ALINITY = 32.74, SID (B)(6) (50 YEAR OLD FEMALE): ATELLICA RESULT = 28.94, ALINITY RESULT = 160.89, PEG ATELLICA = 16.5, PEG ALINITY = 37.42, SID (B)(6) (36 YEAR OLD MALE): ATELLICA RESULT = 25.12, ALINITY RESULT = 49.16, PEG ATELLICA = 13.78, PEG ALINITY = 19.6, SID (B)(6) (17 YEAR OLD FEMALE): ATELLICA RESULT = 21.97, ALINITY RESULT = 32.87, PEG ATELLICA =21.68, PEG ALINITY = 27.54, SID (B)(6) (51 YEAR OLD FEMALE): ATELLICA RESULT = 16.25, ALINITY RESULT = 30.35, PEG ATELLICA = 12.1, PEG ALINITY = 15.26, SID (B)(6) (43 YEAR OLD FEMALE): ATELLICA RESULT = 52.22, ALINITY RESULT = 88.82, PEG ATELLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080819 ↗
• MalfunctionOct 6, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINTY I PROLACTIN RESULTS FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: ALL INITIAL PROLACTIN RESULTS LISTED ARE FROM (B)(6) 2025. PROLACTIN (PROLACTIN RESULT UNITS: NG/ML, REFERENCE VALUE: MALE: 3.46-19.40, FEMALE: 5.18-26.53) SID (B)(6), MALE, INITIAL PROLACTIN RESULT 9.45 NG/ML, REPEATED ON ANOTHER MACHINE 17.87 NG/ML, REPEATED AFTER NEW CALIBRATION 19.93 NG/ML. SID (B)(6), FEMALE, INITIAL PROLACTIN RESULT 18.31 NG/ML, REPEATED ON ANOTHER MACHINE 33.26 NG/ML, REPEATED AFTER NEW CALIBRATION 35.58 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23220664 ↗
• MalfunctionDec 16, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR ONE SAMPLE. SID (B)(6), INITIAL RESULT = 108.04 NG/ML (LOT 65355UD00), REPEAT RESULT AT A REFERENCE LAB = 38.87 NG/ML, SAME SAMPLE WAS TESTED ON ANOTHER LOT WITH RESULT OF = 107.37 NG/ML (LOT 67389UD00). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939338 ↗
• MalfunctionDec 16, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR ONE SAMPLE. SID (B)(6), INITIAL RESULT = 108.04 NG/ML (LOT 65355UD00), REPEAT RESULT AT A REFERENCE LAB = 38.87 NG/ML, SAME SAMPLE WAS TESTED ON ANOTHER LOT WITH RESULT OF = 107.37 NG/ML (LOT 67389UD00). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939325 ↗
• MalfunctionApr 8, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY POSITIVE ALINITY I PROLACTIN FOR ONE SAMPLE WHEN COMPARED TO OTHER METHODS. (ABBOTT REFERENCE 3.46 TO 19.40 NG/ML). (B)(6) 2024 SID (B)(6) ALINITY INITIAL RESULT 58.58 NG/ML, REPEAT RESULT 56.31 NG/ML. SIEMENS RESULTS 11.10 NG/ML (SIEMENS REFERENCE RANGE 2.10 TO 17.70 NG/ML). BECKMAN RESULT 19.95 NG/ML (BECKMAN REFERENCE RANGE 2.10 TO 17.10 NG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059579 ↗
• MalfunctionNov 6, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2023 SID (B)(6) = 108.08 NG/ML, ANOTHER ALINITY = 112.81 NG/ML. (B)(6) 2023 SAMPLE TESTED AT ANOTHER LABORATORY = 17.6 NG/ML (METHODOLOGY UNKNOWN). NEW SAMPLE: (B)(6) 2023 SID (B)(6) = 80.71 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077824 ↗
• MalfunctionNov 6, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2023 SID (B)(6) = 108.08 NG/ML, ANOTHER ALINITY = 112.81 NG/ML (B)(6) 2023 SAMPLE TESTED AT ANOTHER LABORATORY = 17.6 NG/ML (METHODOLOGY UNKNOWN) NEW SAMPLE: (B)(6) 2023 SID (B)(6) = 80.71 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077822 ↗
• MalfunctionMar 30, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS ON SEVERAL PATIENTS WHEN COMPARE TO CENTAUR XP ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) 1470 MIU/ML /ON (B)(6) 2022 ON CENTAUR=360 MIU/L /ON (B)(6)2022 ON ATELLICA=213 MIU/L. ON (B)(6) 2022 SID (B)(6) =1473 MIU/L /ON (B)(6) 2022 ON CENTAUR =390 MIU/L. ON (B)(6) 2022 SID (B)(6) =2540 MIU/L /ON (B)(6) 2022 ON CENTAUR=562.6 MIU/L /ON (B)(6) 2022 ON ARCHITECT I2SR=2480 MIU/L. ON (B)(6) 2022 SID (B)(6) =1662 MIU/L /ON (B)(6) 2022 ON CENTAUR=676.7 MIU/L /ON (B)(6) 2022 ON ARCHITECT I2SR=1546 MIU/L. ON (B)(6) 2022 SID (B)(6) =1500 MIU/L /ON (B)(6) 2022 ON CENTAUR=490.5 MIU/L /ON (B)(6) 2022 ON ARCHITECT I2SR=1286 MIU/L. ON (B)(6) 2022 SID (B)(6) =1320 MIU/L /ON (B)(6) 2022 ON CENTAUR=954 MIU/L .THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13949971 ↗
• MalfunctionNov 24, 2021High Test Results; High Test Results

  THE CUSTOMER STATED THAT FALSELY ELEVATED ALINITY I PROLACTIN RESULTS WERE GENERATED FOR TWO PATIENT SAMPLES. THE ELEVATED VALUES DID NOT MATCH THE CLINICAL HISTORY. TESTING OF THE SAMPLES AT DIFFERENT LABORATORIES GENERATED LOWER VALUES USING ALTERNATE METHODS. THE FOLLOWING DATA WAS PROVIDED. PATIENT 1 SID (B)(4): DRAWN ON (B)(6) 2021. ALINITY 44.72 AND SIEMENS 9.80 NG/ML SID (B)(4): DRAWN AGAIN ON (B)(6) 2021. ALINITY 43.49, SIEMENS 11.0, DXL 17.79 AND ROCHE 17.0 NG/ML PATIENT 2 SID (B)(4): DRAWN ON (B)(6) 2021. ALINITY 74.52 AND SIEMENS 14.5 NG/ML SID(B)(4): DRAWN AGAIN ON(B)(6) 2021. ALINITY 60.82, SIEMENS 11.0, DXL 17.63 AND ROCHE 20.0 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872321 ↗
• MalfunctionSep 3, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED AND ABOVE THE REFERENCE RANGE ALINITY PROLACTIN RESULTS ON MULTIPLE PATIENTS. THOSE PATIENT SAMPLES SEND OUT FOR RETESTING AND RESULTS WERE NEGATIVE. THE RESULTS ARE AS FOLLOW ALINITY, SIEMENS AND THEN BECKMAN FROM (B)(6) 2020 SID (B)(6) FEMALE PROLACTIN=52.96 NG/DL/17.95 NG/ML/NO RESULT. SID (B)(6) FEMALE PROLACTIN=33.05 NG/DL/24.77 NG/ML/NO RESULT. SID (B)(6) FEMALE PROLACTIN=13.02 NG/DL/8.70 NG/ML/ NO RESULT. SID (B)(6) FEMALE PROLACTIN=11.19 NG/DL/8.05 NG/ML/NO RESULT. SID (B)(6) MALE PROLACTIN=26.78 NG/DL/12.24 NG/ML/NO RESULT. SID (B)(6) FEMALE PROLACTIN=77.71 NG/DL/19.87 NG/ML/27.79 NG/ML. SID (B)(6) FEMALE PROLACTIN=35.0 NG/DL/ 22.11 NG/ML/ NO RESULT. SID (B)(6) FEMALE PROLACTIN=20.97 NG/DL/9.21 NG/ML/NO RESULT. SID (B)(6) MALE PROLACTIN=9.73 NG/DL/7.26 NG/ML/NO RESULT. SID (B)(6) FEMALE PROLACTIN=22.62 NG/DL/5.89 NG/ML/10.02 NG/ML. SID (B)(6) MALE PROLACTIN=31.52 NG/DL/8.77 NG/ML/NO RESULT. SID (B)(6) FEMALE PROLACTIN=28.48 NG/DL/12.97 NG/ML/NO RESULT. (B)(6) YEAR OLD FEMALE PROLACTIN=18.14 NG/DL/ 12.52 NG/ML/NO RESULT. (B)(6) YEAR OLD FEMALE PROLACTIN=33.50 NG/DL/24.66 NG/ML/NO RESULT. (B)(6) YEAR OLD MALE PROLACTIN=66.86 NG/DL/34.18

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10489288 ↗