Alinity 07P7030Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 00380740121822), received between Nov 21, 2018 and Sep 28, 2026 — classified as 168 malfunctions.

The most frequently reported specific device problem is “High Test Results” (142 reports).

1 FDA recall record name this device's identifier.

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. Nov 21, 2018Terminated

   Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

   Z-0665-2019 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923280 ↗
• MalfunctionSep 28, 2026High Test Results

  The customer reported falsely elevated Alinity I Free T4 generated from Alinity i Processing Module (SN:(b)(6)) and provided the following data for a 74 year old female patient:On (b)(6)2026, Sample ID (b)(6) initial result was 24.4 pmol/L and when repeated on another Alinity i Processing Module, the result was 13.7 pmol/ L (Customer Normal range: 9-19.9 pmol/L).Other laboratory data provided:TSH was 2.29 mIU/L (Reference range: 0.35-4.94)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 50916380 ↗
• MalfunctionSep 21, 2026High Test Results

  The customer reported falsely elevated Alinity i Free T4 results for multiple patients. The following data were provided:SID (b)(6)(female, born 1947)(7SEP2026)Initial: >64.35 pmol/L,Repeat: 19.13 pmol/L, 17.70 pmol/L.SID (b)(6)(male, born 1979)((b)(6) 2026)Initial: >64.35 pmol/L.Repeat: 15.31 pmol/L. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846171 ↗
• MalfunctionAug 18, 2026Low Test Results

  The customer observed falsely depressed Alinty i Free T4 results for one sample. The following data was provided (Free T4 normal range 9-19 pmol/L):(b)(6) 2026 (30-year-old female)SID (b)(6) initial result 8.58 pmol/L (Lot 87264UD00), repeated on 31 July 2026 8.08 / 8.81 / 9.10 pmol/L.No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299869 ↗
• MalfunctionAug 18, 2026Low Test Results

  The customer observed falsely depressed Alinty i Free T4 results for one sample. The following data was provided (Free T4 normal range 9-19 pmol/L):(female, 68-year-old)(b)(6) 2026 SID (b)(6) initial result 10.27 pmol/L (Lot 86129UD00), repeated 8.77 and 9.63 pmol/L (Lot 86129UD00). No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299805 ↗
• MalfunctionAug 17, 2026Low Test Results

  The customer observed falsely depressed Alinity i Free T4 results generated for patient samples. The following data was provided (Customer¿s reference range 0.75-1.22 ng/dL):Sample ID (b)(6), (41-year-old Female) Initial result = 0.69 ng/dL, repeat = 0.84 ng/dL.Sample ID (b)(6), (39-year-old Female) Initial result = 0.68 ng/dL, repeat = 0.76 ng/dL.Sample ID (b)(6), (36-year-old Female) Initial result = 0.70 ng/dL, repeat = 0.79 ng/dL.Sample ID (b)(6), (b)(6) Initial result = 0.74 ng/dL, repeat = 0.88 ng/dL.Sample ID (b)(6), (62-year-old Female) Initial result = 0.73 ng/dL, repeat = 0.87 ng/dL.Sample ID (b)(6), (50-year-old Female) Initial result = 0.67 ng/dL, repeat = 0.76 ng/dL.Sample ID (b)(6), (45-year-old Female) Initial result = 0.73 ng/dL, repeat = 0.84 ng/dL.Sample ID (b)(6), (20-year-old Female) Initial result = 0.66 ng/dL, repeat = 0.75 ng/dL .No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50275427 ↗
• MalfunctionAug 12, 2026High Test Results

  The customer observed falsely elevated Alinity i Free T4 results for two samples. The following data was provided (normal range 9.01 to 19.05 pmol/L):(b)(6) 2026 Patient 1 (79-year-old female)Initial result was 19.31 pmol/L, specimen was retested again within 45 min interval, and result was 16.58 / 18.07 / 17.35 pmol/L,Patient 2 (53-year-old female)Initial result was 22.96 pmol/L, specimen was retested again within 45 min interval, and result was 13.50 pmol/L. The customer recentrifuged specimen and results were 13.82 and 14.06 pmol/L. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224329 ↗
• MalfunctionJun 8, 2026Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I FREE T4 RESULT FOR 2-MONTH-OLD MALE PEDIATRIC PATIENT. THE PATIENT HAS A HISTORY OF CONGENITAL CMV AND COMPLETED TREATMENT WITH VALGANCICLOVIR. (CUSTOMER PROVIDED REFERENCE RANGE FOR CHILD: 11.40¿21.90 PMOL/L). (B)(6) 2026 SID (B)(6) INITIAL RESULT = 10.7 PMOL/L. ADDITIONAL LAB RESULT PROVIDED: TSH RESULT = 1.26 MIU/L WITHIN NORMAL RANGE (0.35¿4.94 MIU/L). (B)(6) 2026 SID (B)(6) PATIENT TESTED AT ANOTHER LABORATORY FREE T4 RESULT = 14.54 PMOL/L, NORMAL TSH RESULT (NO SPECIFIC RESULT PROVIDED). ON (B)(6) 2026 NEW SAMPLE FREE T4 RESULT WITH SID (B)(6) = 10.97 PMOL/L, (NEW REFERENCE RANGE. DUE TO PATIENT AGE FOR FREE T4: 9.36¿14.49 PMOL/L) WITHIN NORMAL RANGE. ADDITIONAL LAB RESULT PROVIDED: TSH 1.60 MIU/ML WITHIN NORMAL RANGE (0.35¿4.94 MIU/L). SAMPLE WITH SID (B)(6) WAS FROZEN AND RETESTED ON (B)(6) 2026 ON (B)(6) WITH A RESULT = 12.34 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428171 ↗
• MalfunctionJun 4, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR A 57-YEAR-OLD WHITE FEMALE. PATIENT HISTORY INCLUDES: RHEUMATOID ARTHRITIS, FIBROMYALGIA, IBS, ASTHMA, TYPE 2 DIABETES, HAY FEVER, ANXIETY / PANIC DISORDER AND TAKING MEDICATIONS BUDESONIDE + FORMOTEROL INHALER, CETIRIZINE, FEXOFENIDINE, FOLIC ACID, HYOSCINE BUTYLBROMIDE, IBUPROFEN, LEFLUNOMIDE, METHOTREXATE, OMEPRAZOLE, PARACETAMOL, PREDNISOLONE, SALBUTAMOL, AND SERTRALINE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.0-19.1 PMOL/L): ON (B)(6) 2026, SID (B)(6), INITIAL FREE T4 RESULT= 26.10 PMOL/L; REPEAT RESULTS= 18.54 PMOL/L, 15.95 PMOL/L; (B)(6) 2026, REPEAT RESULTS= 12.31 PMOL/L, 11.32 PMOL/L ADDITIONAL RESULTS PROVIDED: PT RESULT= 9.6 (REFERENCE RANGE 9.7-12.0), INR RESULT= 0.5, APTT RESULT= 22.9. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25400385 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT. THE SAMPLES WERE CENTRIFUGED AND REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) 26 YEAR OLD MALE PATIENT DIAGNOSED WITH DECOMPENSATED DILATED CARDIOMYOPATHY. PROCESSED ON (B)(6) 2026 INITIAL RESULT = >64.3 REPEAT RESULTS = 13.89 AND 14.56 PMOL/L. HISTORICAL RESULT FROM (B)(6) 2026 = 17.37 PMOL/L. THE PATIENT IS ON THE FOLLOWING MEDICATIONS: CASPOFUNGIN, ZOPICLONE, CEFAZOLIN, MORPHINE, MYCOPHENOLATE, METHYLPREDNISOLONE, TEICOPLANIN, PIPERACILLIN, TAZOBACTAM, FUROSEMIDE, LEVETIRACETAM, HYDRALAZINE, NICARDIPINE, LANSOPRAZOLE, TRAMADOL, CHLORAMPHENAMINE, CYCLIZINE, NALOXONE, MELATONIN, HEPARIN, ACTRAPID INSULIN, ONDANSETRON. SID (B)(6) 80 YEAR OLD MALE PATIENT, ELECTIVE ANGIOGRAM FOR EXERTIONAL ANGINA AND SHORTNESS OF BREATH ON EXERTION, PROCESSED ON (B)(6) 2026 INITIAL RESULT = 20.21 REPEAT RESULTS = 15.26 AND 15.51 PMOL/L THE PATIENT IS ON THE FOLLOWING MEDICATIONS: CLOPIDOGREL, BUDESONIDE + FORMOTEROL INHALER, DARBEPOETIN ALFA SC, NITRATES SUBLINGUAL, HYDROXOCOBALAMIN IM, ASPIRIN, LEVOTHYROXINE, RAMIPRIL, SIMVASTATIN. REFERENCE RANGE 9-19.1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150768 ↗
• MalfunctionMay 11, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR A 32-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 9.0-19.0 PMOL/L): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2026, WAS >64.35, REPEAT RESULT WAS 19.13, REPEAT RESULTS, ON ANOTHER ANALYZER, WERE 18.29, 18.17, AND 18.39 PMOL/L. THE TSH RESULTS FOR THIS PATIENT WERE ALSO PROVIDED: 2.521, REPEAT WAS 2.631 MIU/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136271 ↗
• MalfunctionMay 8, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE : 0.70 - 1.48 NG/DL SAMPLE ID (B)(6) - MALE , 1 YEAR OLD. FREE T4 INITIAL RESULT WAS 2.88 NG/DL AND REPEAT RESULT WAS 0.76 NG/DL OTHER LABORATORY VALUES PROVIDED: FT3 : 2.46 PG/ML TSH : 1.8672 UIU/ML SAMPLE ID :(B)(6) - FEMALE , 16 YEAR OLD. FREE T4 INITIAL RESULT WAS > 5.00 NG/DL AND REPEAT RESULT WAS 1.16 NG/DL 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 25125868 ↗
• MalfunctionApr 30, 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), THE INITIAL RESULT WAS > 5.00 NG/DL AND REPEAT RESULT WAS 1.36 NG/DL. THE CUSTOMER PROVIDED ADDITIONAL LABORATORY DATA: TSH: WAS 0.4590 UIU/ML & 0.4560 UIU/ML FREE T3: WAS 3.13 PG/ML & 2.73 PG/ML TRAB: WAS 1.10 IU/L TG WAS 14.24 NG/ML. HISTORICAL TSH VALUES: THE CUSTOMER COMMUNICATED THAT THE PATIENT'S TSH LEVELS ARE IMPROVING OVER THE PAST SIX MONTHS: 0.2 , 0.4 , 0.5. PATIENT INFORMATION: 80-YEAR-OLD MALE WITH A MEDICAL HISTORY OF PSVT (PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA) AND HYPERTHYROIDISM. MEDICATIONS: THIAMAZOLE & WARFARIN THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046373 ↗
• MalfunctionApr 3, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9 - 23 PMOL/L): (B)(6) 2026, SID (B)(6), INITIAL FREE T4 RESULT= 48.6 PMOL/L; REPEAT RESULTS= 17.4 AND 16.6 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777815 ↗
• MalfunctionApr 3, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULTS ON A 88YRS OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=> 5.00 NG/ML /REPEATED=1.40 NG/ML. LABORATORY REFERENCE RANGE FOR FT4=0.7 TO 1.48 NG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775034 ↗
• MalfunctionMar 16, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR A 58-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 9-19 PMOL/L): SAMPLE ID (B)(6), INITIAL RESULT WAS 42, REPEAT RESULT WAS 15 PMOL/L. ADDITIONAL LAB RESULTS WERE PROVIDED WITH TSH RESULT BEING 1.8 MIU/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606540 ↗
• MalfunctionMar 11, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR A 3-YEAR-OLD FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE: 0.7 - 1.48 NG/DL). (B)(6) 2026 SID (B)(6) INITIAL RESULT = 1.60 NG/DL, REPEAT RESULT = 1.05 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567732 ↗
• MalfunctionFeb 11, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE 75-YEAR-OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED WITH A LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID(B)(6): ALINITY SERIAL NUMBER (B)(6) RESULT = 27.48 PMOL/L REPEAT RESULT = 17.94 PMOL/L. ALINITY SERIAL NUMBER (B)(6) RESULT = 17.84 PMOL/L. ALINITY SERIAL NUMBER (B)(6) RESULT = 17.16 PMOL/L. REFERENCE RANGE IS 9-19 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316193 ↗
• MalfunctionJan 30, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE PATIENT. THE SAMPLE WAS FROZEN BETWEEN EACH MEASUREMENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 12-22 PMOL/L): FIRST SAMPLE (THE PATIENT IS POSITIVE FOR RHEUMATOID FACTOR (RF)), SID (B)(6), INITIAL FREE T4 RESULT 35.3 PMOL/L ((B)(6) 2025), REPEATED 18.1 ((B)(6) 2025), 23.2 PMOL/L ((B)(6) 2025), AND 26.9 PMOL/L ((B)(6) 2025). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220469 ↗
• MalfunctionJan 27, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA FOR SAMPLE ID (B)(6): ON (B)(6) THE RESULT WAS 1.33 NG/DL, ON (B)(6), THE RESULT WAS 1.75 NG/DL, ON (B)(6) THE RESULTS WERE 1.12 NG/DL & 1.10 NG/DL, CUSTOMER REFERENCE RANGE: 0.81 TO 1.32 NG/DL. PATIENT INFORMATION: 16 YEAR OLD FEMALE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER REPORTED MORE PATIENTS WITH FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) (MALE, 47 YEARS OLD): ON (B)(6) RESULTS WERE 1.09 NG/DL (FROM SN: (B)(6)) AND 2.28 NG/DL (FROM SN: (B)(6)) ON (B)(6) RESULTS WERE 1.05 NG/DL (FROM SN: (B)(6)) AND 1.03 NG/DL (FROM SN: (B)(6)). SAMPLE ID (B)(6) (FEMALE, 37 YEARS OLD): ON (B)(6) RESULTS WERE 1.14 NG/DL (FROM SN: (B)(6)) AND 1.42 NG/DL (FROM SN: (B)(6)) ON (B)(6) RESULTS WERE 1.08 NG/DL (FROM SN: (B)(6)) AND 1.09 NG/DL (FROM SN: (B)(6)). SAMPLE ID (B)(6) (GENDER AND AGE NOT PROVIDED): ON (B)(6) THE RESULT WAS 4.06 NG/DL (FROM SN: (B)(6)). ON (B)(6) THE RESULTS WERE 1.69 NG/DL (FROM SN: (B)(6)), 0.97 NG/DL (FROM SN: (B)(6)), 1.29 NG/DL (FROM SN: (B)(6)), 1.82 NG/DL (FROM SN: (B)(6)) & 0.96 NG/DL (FROM SN: (B)(6)). THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192490 ↗
• MalfunctionJan 26, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 10.8-20.2 PMOL/L): SAMPLE ID (B)(6) INITIAL RESULT WAS >64.35, REPEAT RESULT WAS 15.9, REPEAT RESULT, ON ANOTHER ANALYZER, WAS 17.3 PMOL/L. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: TSH RESULT WAS 3.03, REPEAT RESULT WAS 3.02 UIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180121 ↗
• MalfunctionJan 12, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULT FOR A FEMALE PATIENT IN HER 30S WITH A MEDICAL HISTORY OF GRAVE¿S DISEASE AND IS CURRENTLY ON THYRADIN (THYROID HORMONE REPLACEMENT MEDICATION) GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: PREVIOUS FT4 RESULT (TESTED IN (B)(6) 2024) = 1.30 NG/DL. ON (B)(6) 2025, SID (B)(6): INITIAL FT4 RESULT = 2.16 NG/DL (DUE TO THE PREVIOUS VALUE, THE CUSTOMER RETESTED THE SAMPLE). REPEAT FT4 RESULTS: FIRST REPEAT (SID 84) = 1.41 NG/DL; SECOND REPEAT (SID 84-2) = 1.35 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24042854 ↗
• MalfunctionJan 12, 2026High Test Results

  THE CUSTOMER OBSERVED ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS > 64 (CUSTOMER REFERENCE RANGE 9-19 PMOL/L). THE CUSTOMER REPORTED THAT THERE WAS NOT ENOUGH SAMPLE TO RETEST. THE CUSTOMER PROVIDED THE FOLLOWING HISTORICAL AND ADDITIONAL THYROID TEST RESULTS: ON (B)(6) 2024 (SAMPLE ID (B)(6), FREE T4 WAS 15 PMOL/L WAS AND TSH WAS 3.42 MU/L, ON (B)(6) 2025 (SAMPLE ID (B)(6), FREE T4 WAS 15 PMOL/L WAS AND TSH WAS 3.40 MU/L, ON (B)(6) 2024 (SAMPLE ID (B)(6), FREE T4 WAS 14 PMOL/L WAS AND TSH WAS 5.68 MU/L, ON (B)(6) 2025, SAMPLE ID (B)(6), TSH WAS 1.29 MU/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 24040641 ↗
• MalfunctionJan 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED ERRATIC ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE CUSTOMER NOTES THAT THE RESULTS WERE WITHIN NORMAL RANGE, BUT LATER THE RESULTS WERE OUT OF REFERENCE RANGE. THE FOLLOWING DATA WAS PROVIDED: REFERENCE RANGES: ADULTS: 0.75 TO 1.22 NG/DL. PEDIATRICS: < 1 MONTH NOT AVAILABLE 1 TO 23 MONTHS: 0.86 TO 1.32 NG/DL. 2 TO 12 YEARS: 0.84 TO 1.32 NG/DL. 13 TO 18 YEARS: 0.81 TO 1.32 NG/DL. SID (B)(6), 9-YEAR-OLD MALE, INITIAL FREE T4 RESULT= 1.30 NG/DL; REPEAT RESULT= 1.93 NG/DL. SID (B)(6), 39-YEAR-OLD MALE, INITIAL FREE T4 RESULT= 1.06 NG/DL; REPEAT RESULT= 1.30 NG/DL. SID (B)(6), 73-YEAR-OLD MALE, INITIAL FREE T4 RESULT= 1.32 NG/DL; REPEAT RESULT= 1.55 NG/DL. FURTHER TESTING OF THE SAMPLES WAS PERFORMED: SID (B)(6) (B)(6) 2025, ANALYZER (B)(6), FREE T4 RESULT= 1.30 NG/DL (B)(6) 2025, AFTER HOMOGENIZING THE SAMPLE, ANALYZER (B)(6), RESULT= 1.93 NG/DL; ANALYZER (B)(6), RESULT= 1.96 NG/DL, 1.88 NG/DL, 1.87 NG/DL (B)(6) 2025, AFTER RECENTRIFUGING THE SAMPLE, ANALYZER (B)(6) RESULT= 1.02 NG/DL; ANALYZER (B)(6) RESULT= 1.06 NG/DL; (B)(6) 2025, ANALYZER (B)(6) RESULT= 1.06 NG/DL SID (B)(6) (B)(6) 2025, ANALYZER (B)(6), FREE T4 RESULT= 1.06 NG/DL (B)(6) 2025, AFTER HOMOGENI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005213 ↗
• MalfunctionDec 24, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SAMPLE 1 SID (B)(6) INITIAL RESULT >64.350 PMOL/L, REPEATED 10.341 AND 12.188 PMOL/L, TSH 0.845 MIU/L SERUM LIPAEMIC RESULT 61.00 INDEX (1+). SAMPLE 2 SID (B)(6) INITIAL RESULT >64.350 PMOL/L, REPEATED 49.596 / 55.342 / 43.883 PMOL/L, TSH RESULT <0.008 MIU/L SERUM HEMOLYSE RESULT 166 INDEX (2+). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888423 ↗