Alinity 03R6501Recalls & reported problems

Summary

The FDA's MAUDE database contains 911 adverse event reports that list this exact device (DI 00380740137366), received between Jul 7, 2018 and Sep 30, 2026 — classified as 23 injuries, 888 malfunctions.

The most frequently reported specific device problem is “High Test Results” (274 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 19, 2023Open, Classified

   The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

   Z-0680-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 911 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026False Positive Result

  The customer observed false reactive Alinity i Anti-HBc results generated on the Alinity i PROCESSING MODULE. The following data was provided:(43-year-old female) SID (b)(6) initial Anti-HBc result 1.16 S/CO, repeated 1.16 / 1.04 / 0.10 / 0.11 / 0.13 S/CO.(48-year-old male) SID (b)(6) initial Anti-HBc result 1.51 S/CO, repeated 1.70 / 1.74 / 0.11 / 0.12 / 0.11 S/CO.(31-year-old female) SID (b)(6) initial Anti-HBc result 2.16 S/CO, repeated 2.27 / 2.40 / 0.25 / 0.18 / 0.14 S/CO.SID (b)(6) initial result 1.28 S/CO (reactive), repeated 1.44 and 1.35 S/CO,SID (b)(6) initial result 1.00 S/CO (reactive), repeated 1.22 and 1.15 S/CO,SID (b)(6) initial result 1.13 S/CO (reactive), repeated 1.30 and 1.41 S/CO,SID (b)(6) initial result 2.67 S/CO (reactive), repeated 2.78 and 0.11 S/CO.No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947484 ↗
• MalfunctionSep 29, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938610 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932377 ↗
• MalfunctionSep 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922284 ↗
• MalfunctionSep 24, 2026High Test Results

  The customer observed falsely elevated Alinity i Free T4 results for multiple patients. Results were released from the laboratory. Same sample was used for the repeat testing. The following results were provided: (Customer provided reference range: : 9.00 to 20.00 pmol/L).(b)(6) 2026, SID (b)(6); Initial result => 64.35 pmol/L, repeat results on (b)(6) 2026 (b)(6)= 19.72 pmol/L and 11SEP2026= 20.22 pmol/L.(b)(6) 2026, SID: (b)(6); Initial result = 22.55 pmol/L, repeat results on (b)(6) 2026 (b)(6)= 13.27 pmol/L.(b)(6) 2026, SID: (b)(6); Initial result = 24.48 pmol/L, repeat results on (b)(6) 2026 (b)(6)= 13.18 pmol/L.No additional patient information was available. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881801 ↗
• MalfunctionSep 23, 2026High Test Results

  The customer reported falsely elevated Alinity I STAT High Sensitivity Troponin-I results for multiple patients. The following data was provided (customer provided diagnostic cutoff is >/= 28 ng/L):(b)(6) 2026, SID (b)(6) (49 year old female):initial result = 46.8 ng/L, repeat = 96.1 ng/mL, repeat on another analyzer = 6.3 ng/L.(b)(6) 2026, SID (b)(6) (41 year old female): Initial = 54.4 ng/L, repeat was < 2.7 ng/L, repeat on another analyzer was <2.7 ng/:A new sample was collected: SID (b)(6).Initial = 11.9 ng/L, repeat was <2.7 ng/L, repeat on another analyzer was <2.7 ng/L. The customer believes the results generated on the other analyzer are the correct results.No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869570 ↗
• MalfunctionSep 21, 2026Smoking

  The customer observed smoke from the RSH Load/Unload Board during a module restart. The Alinity i Processing Module, serial number (b)(6), was immediately shut down. As a corrective action, the PSCB RSM Load/Unload Controller board and the RSM 2 Axis Driver board were replaced. No impact to patient management and no impact to user safety was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841613 ↗
• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791566 ↗
• MalfunctionAug 31, 2026High Test Results

  The customer reported falsely elevated Alinity i Free T4 generated from Alinity i Processing Module and provided the following data:Sample ID (b)(6) initial FT4 result was >64.35 pmol/L and the repeat result was 14.43 pmol/L. The reference range for FT4 is 9 - 19 pmol/L.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525232 ↗
• MalfunctionAug 27, 2026Thermal Decomposition of Device

  During service of the Alinity i Processing Module, it was observed the WZ1 motor cable connectors were corroded and burnt out. Service replaced the WZ1 Lift motor and WZ1 cabling. There were no signs of fire or smoke. There was no impact to patient management or user safety.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479040 ↗
• MalfunctionAug 19, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326399 ↗
• MalfunctionAug 14, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254361 ↗
• MalfunctionJun 17, 2026Thermal Decomposition of Device; Smoking

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING STARTUP OF THE ALINITY I PROCESSING MODULE, SMOKE AND AN ACRID ODOR WERE OBSERVED COMING FROM THE SERVO RACK. THE INSTRUMENT WAS IMMEDIATELY POWERED DOWN, AND THE SMOKE SUBSIDED. STAFF WERE INSTRUCTED NOT TO POWER ON THE ANALYZER UNTIL SERVICE WAS COMPLETED. UPON INSPECTION, A COMPONENT ON THE 25-AMP SERVO BOARD WAS FOUND TO BE MELTED. THE 25-AMP SERVO BOARD WAS REPLACED, AND THE ISSUE WAS RESOLVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537963 ↗
• MalfunctionJun 2, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL -HCG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 38-YEAR-OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED, AND NEGATIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): INITIAL RESULT (B)(6) = 60 IU/L (POSITIVE) REPEAT RESULT (B)(6) = <3 IU/L, <3 IU/L, <3 IU/L (ALL NEGATIVE) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361139 ↗
• MalfunctionJun 1, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HBSAG RESULTS GENERATED ON THE ALINITY I AM PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026 SID (B)(6) INITIAL RESULT HBSAG 95.50 S/CO (REACTIVE), REPEATED NONREACTIVE (NO VALUE PROVIDED). ON (B)(6) 2026, THE CUSTOMER INFORMED US THAT THEY REPEATED SID (B)(6) ON (B)(6) 2026, AND THE HBSAG RESULT WAS 749.91 S/CO (REACTIVE), NEUTRALIZATION INDEX 1.55% (CONFIRMED POSITIVE). OTHER RESULTS PROVIDED: ANTI HCVII 0.06 S/CO (NONREACTIVE). HIV 0.05 S/CO (NONREACTIVE). THE CUSTOMER NOTED THAT SID (B)(6) (KNOWN POSITIVE HEP B) WAS RUN AT THE SAME TIME, NEXT TO SID (B)(6). THE RESULT FOR SID (B)(6) WAS 4175.41 S/CO (REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349028 ↗
• MalfunctionJun 1, 2026Thermal Decomposition of Device; Smoking

  THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE INSPECTING THE ALINITY I PROCESSING MODULE, AND OBSERVED THE FOLLOWING INSTRUMENT ERROR MESSAGES: 0148 ¿ INITIALIZATION ERROR, 3316 ¿ VACUUM INITIALIZATION FAILED, 3320 ¿ VACUUM SYSTEM FAILED. AND 0148 WITH ERROR CODE, 5579-REAGENT SUPPLY CENTER INITIALIZATION FAILED, 5654-REAGENT CAROUSEL MONITORING ERROR, 5674-REAGENT CAROUSEL OPERATION FAILED, 5007-D708-REAGENT CAROUSEL SERVO DRIVE 5760-G005. BOTH CAROUSEL AND VACUUM PUMP WERE MAKING SOME NOISE DURING INITIALIZATION. THE FSE FIRST REPLACED THE SERVO DRIVE. THE FSE INSPECTED THE CAROUSEL FOR ANY OBSTRUCTION; HOWEVER, IT WAS MOVING SMOOTHLY BUT NOTICED ONE WHEEL WAS GLIDING INSTEAD OF ROTATING. THE FSE REPLACED THE WHEEL AND REBUILT THE VACUUM PUMP WITH THE VACUUM REPAIR KIT. THE FSE TRIED TO RECALIBRATE THE REAGENT CAROUSEL AND THE CAPACITOR BLEW CAUSING THE PLUG TO BE CHARRED AND DAMAGED. THE FSE OBSERVED VISIBLE SMOKE FROM THE CAPACITOR. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348419 ↗
• MalfunctionMay 26, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS ON A 45YRS OLD MALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2026 SID (B)(6) INITIAL=57.0 NG/L. REDRAWN AND REPEATED SID (B)(6) =9.0 NG/L /REPEATED=9 NG/L. CUSTOMER REFERENCE RANGE FOR ALINITY TROPONIN= 0.0 TO 53 NG/L; CRITICAL HIGH RANGE=> 120 NG/L; LAB CUT OFF RANGE= 60.0 NG/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285642 ↗
• MalfunctionMay 20, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I B-HCG RESULTS ON A 47YRS OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON(B)(6) 2026 (B)(6) INITIAL=49.20 MIU/ML (> 25.0 MIU/ML =POSITIVE) /REDRAWN AND REPEATED ON (B)(6) 2026 SID (B)(6) =< 1.2 MIU/ML (< OR =5.0 MIU/ML=NEGATIVE) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233861 ↗
• MalfunctionMay 18, 2026Smoking

  THE CUSTOMER REPORTED HEARING A NOISE FOLLOWED BY SLIGHT SMOKE EMITTING FROM THE ALINITY I PROCESSING MODULE UPON POWERING IT UP AFTER REPLACING A FAULTY ELECTRICAL OUTLET PLUG. IT WAS NOTED THAT THE OUTLET PLUG HAD A POOR CONNECTION AND VISIBLE BURN MARKS ON THE PINS. THE FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE AND REPLACED THE POWER SUPPLY ON THE ALINITY I PROCESSING MODULE. NO INJURIES OR HARM TO THE USER WERE REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202574 ↗
• MalfunctionMay 14, 2026Imprecise or Erratic Results

  THE CUSTOMER OBSERVED DISCREPANT FREE T4, TOTAL PSA AND TSH RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: FREE T4 RESULTS: SAMPLE ID (B)(6), INITIAL = >5.00, REPEAT = 0.95. TOTAL PSA RESULTS: SAMPLE ID (B)(6) INITIAL = 1.53, REPEAT =9.09, SAMPLE ID (B)(6) INITIAL = 0.23, REPEAT =5.19, SAMPLE ID (B)(6) INITIAL = 0.05, REPEAT =1.34. TSH RESULTS: SAMPLE ID (B)(6) INITIAL = 0.06, REPEAT = 2.25, SAMPLE ID (B)(6) INITIAL = 0.00, REPEAT = 0.49, SAMPLE ID (B)(6) INITIAL = 0.01, REPEAT = 0.38. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178365 ↗
• MalfunctionMay 14, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE <52 NG/ML): SID (B)(6), INITIAL TROPONIN RESULT= 1178 NG/L; REPEAT RESULT ON ANOTHER ANALYZER= 23 NG/L PATIENT WAS A 42 YEAR OLD FEMALE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173725 ↗
• MalfunctionMay 14, 2026False Positive Result

  THE CUSTOMER OBSERVED POSITIVE ALINITY I HAVAB IGG RESULTS WHEN PROCESSING ON THE ALINITY I PROCESSING MODULE. ID (B)(6) (FEMALE, 38 YEARS OLD) RESULT 2.23 S/CO POSITIVE, REPEATED RESULT 0.37 S/CO NON-REACTIVE. ID (B)(6) (MALE, 61 YEARS OLD) - FIRST RESULT: 1.22 S/CO REACTIVE, REPETITION: 0.66 S/CO NONREACTIVE. ID (B)(6) (MALE, 26 YEARS OLD) - FIRST RESULT: 1.83 S/CO REACTIVE, REPETITION: 0.71 S/CO NONREACTIVE. ID (B)(6) (MALE, 10 MONTHS) - FIRST RESULT: 1.75 S/CO REACTIVE, REPETITION: 0.42 S/CO NONREACTIVE. ID (B)(6) (FEMALE, 25 YEARS OLD) - FIRST RESULT: 1.66 S/CO REACTIVE, REPETITION: 0.89 S/CO NONREACTIVE. ID (B)(6) (MALE, 27 YEARS OLD) - FIRST RESULT: 1.36 S/CO REACTIVE, REPETITION: 0.68 S/CO NONREACTIVE. ID (B)(6) (FEMALE, 23 YEARS OLD) - FIRST RESULT: 2.39 S/CO REACTIVE, REPETITION: 0.78 S/CO NONREACTIVE. ID (B)(6) (MALE, 23 YEARS OLD) - FIRST RESULT: 5.52 S/CO REACTIVE, REPETITION: 0.47 S/CO NONREACTIVE. ID (B)(6) (FEMALE, 16 YEARS OLD) - FIRST RESULT: 2.52 S/CO REACTIVE, REPETITION: 0.14 S/CO NONREACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173454 ↗
• MalfunctionMay 14, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I INSULIN RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 72-YEAR-OLD FEMALE PATIENT. UPON REPEAT TESTING, THE RESULTS WERE LOWER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): (B)(6) 2026 INITIAL RESULT = 16.20 U/ML, (B)(6) 2026 REPEAT RESULT (ON ANOTHER INSTRUMENT) = 9.8 U/ML, (B)(6) 2026 REPEAT RESULT ON THE ORIGINAL INSTRUMENT POST SERVICE = 9.9 U/ML, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167195 ↗
• MalfunctionMay 7, 2026False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I HAVAB IGG II RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6) (19-YEAR-OLD MALE): INITIAL RESULT ON (B)(6) = POSITIVE, REPEAT ON ANOTHER ALINITY = NEGATIVE. (B)(6) 2026, SID (B)(6) (33-YEAR-OLD MALE): INITIAL RESULT ON (B)(6) = POSITIVE, REPEAT = NEGATIVE, REPEAT ON ANOTHER ALINITY = NEGATIVE. ADDITIONALLY, THE CUSTOMER NOTED A SHIFT UP IN QUALITY CONTROLS. A PRECISION STUDY WAS COMPLETED WITH SID (B)(6) FOR TROUBLESHOOTING PURPOSES: (B)(6) = 0.3, (B)(6) = 0.75, (B)(6) = 0.43, (B)(6) = 1.32, (B)(6) = 0.53, (B)(6) = 1.09, (B)(6) = 0.28, (B)(6) = 1.07, (B)(6) = 0.41, (B)(6) = 0.4. A PATIENT COMPARISON STUDY WAS COMPLETED FOR TROUBLESHOOTING PURPOSES: SAMPLE 1: (B)(6) = 10.8, (B)(6) = 9.61, SAMPLE 2: (B)(6) = 0.14, (B)(6) = 0.12, SAMPLE 3: (B)(6) = 7.25, (B)(6) = 7.48, SAMPLE 4: (B)(6) = 9.08, (B)(6) = 8.53, SAMPLE 5: (B)(6) = 8.07, (B)(6) = 8.18, SAMPLE 6: (B)(6) = 11.03, (B)(6) = 10.20, SAMPLE 7: (B)(6) = 1.26, (B)(6) = 0.73, SAMPLE 8: (B)(6) = 0.34, (B)(6) = 0.34, SAMPLE 9: (B)(6) = 0.09, (B)(6) = 0.10, SAMPLE 10: (B)(6) = 0.21, (B)(6) = 0.27. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112123 ↗
• MalfunctionMay 6, 2026False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I B-HCG RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR AN 11-YEAR-OLD FEMALE PATIENT. SID (B)(6) INITIAL RESULT = 90.8 IU/L, REPEAT RESULT = <2.42 IU/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104756 ↗