Alinity 07P7020Recalls & reported problems
Abbott Ireland · Alinity i Free T4 Reagent Kit 200 Tests · Class 2
Quick summary
This Abbott Alinity free thyroxine test kit is a laboratory reagent kit used to measure thyroid hormone in blood samples. Its 78 reports describe malfunctions, with no deaths and no injuries, mostly falsely high results (64 reports), and some falsely low or imprecise results that differed from repeat or other tests. Reports fell to 14 in the last 12 months from 34 before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00380740121815), received between Feb 22, 2024 and Sep 29, 2026 — classified as 79 malfunctions.
The most frequently reported specific device problem is “High Test Results” (64 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.
Reports received per month
Most reported problems
Device problems
- High Test Results64
- Low Test Results10
- Incorrect, Inadequate or Imprecise Result or Readings3
- Imprecise or Erratic Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions79
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932189 ↗MalfunctionSep 14, 2026Imprecise or Erratic Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763362 ↗MalfunctionAug 17, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50276137 ↗MalfunctionJun 19, 2026High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULTS ON A 73YRS OLD MALE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6), INITIAL=3.24 NG/DL /REPEATED=1.00 NG/DL 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 25562087 ↗MalfunctionMay 7, 2026High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR A 72-YEAR-OLD FEMALE PATIENT. "ON" (B)(6) 2026, ALINITY I FREE T4 RESULT FOR SID (B)(6) WAS 3.57 NG/DL, REPEATED AFTER RE-CENTRIFUGATION >5.00 NG/DL. OTHER TESTING PERFORMED: LUMIPULSE 1.12 NG/DL, COBAS 1.09 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113122 ↗MalfunctionApr 20, 2026Imprecise or Erratic Results
THE CUSTOMER OBSERVED IMPRECISION FOR THE ALINITY FREE T4 ASSAY. THE CUSTOMER HAS ALSO CONFIRMED THAT THEY ARE REPEATING ALL FT4S ABOVE OR BELOW THE REFERENCE RANGE WHERE THE TSH IS WITHIN THE REFERENCE RANGE. NORMAL RANGE OF 9.01 TO 19.05 PMOL/L. THE FOLLOWING DATA WAS PROVIDED: SID / DATE / TIME / RESULTS (B)(6) ON (B)(6) 2026, 2:49:44 PM, EXCEPTION, EXCEPTION 8.4 9.9 (B)(6) ON (B)(6) 2026, 2:30:38 PM, 8.2 8.2 9.3. (B)(6) ON (B)(6) 2026, 4:22:39 PM, 8.3 8.3 9.3. (B)(6) ON (B)(6) 2026, 10:50:56 AM, 8.3 8.3 9.3. (B)(6) ON (B)(6) 2026, 5:48:01 PM, 8.3 8.3 9.3. (B)(6) ON (B)(6) 2026, 1:50:24 PM, 8.4 8.4 9.3. (B)(6) ON (B)(6) 2026, 7:41:42 PM, 7.7 7.7 9.5. (B)(6) ON (B)(6) 2026, 3:09:59 AM 8.5 8.5 9.5. (B)6) ON (B)(6) 2026, 6:40:48 PM, 8.6 8.6 9.6. (B)(6) ON (B)(6) 2026, 3:54:37 PM, 8.6 8.6 9.8. (B)(6) ON (B)(6) 2026, 6:12:00 PM, 8.6 8.6 9.8. (B)(6) ON (B)(6) 2026, 7:20:45 PM, 8.7 8.7 9.8. (B)(6) ON (B)(6) 2026, 7:03:01 PM, 8.9 8.9 9.8. (B)(6) ON (B)(6) 2026, 2:58:48 PM, 8.9 8.9 9.8. (B)(6) ON (B)(6) 2026 4:49:41 PM, 8.8 8.8 9.9. (B)(6) ON (B)(6) 2026, 12:59:49 PM, 9 9 9.9. (B)(6) ON (B)(6) 2026, 5:40:33 PM, 8.4 8.4 10. (B)(6) ON (B)(6) 2026, 2:24:49 PM, 8.7 8.7 10. (B)(6) ON(B)(6) 20
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927943 ↗MalfunctionApr 6, 2026Low Test Results
THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I FREE T4 GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: PATIENT 1: ON (B)(6) 2026, SID (B)(6) FREE T4 RESULT WAS 21.88. THE PATIENT'S PHYSICIAN QUESTIONED THIS RESULT AND WHEN THE SAMPLE WAS REPEATED THE RESULT WAS 21.88. (ALINITY REFERENCE RANGE IS: 9.01-19.05 PMOL/L.). WHEN TESTED ON THE SNIBE PLATFORM, THE RESUTLS WERE 33.5 AND 32.5 (SNIBE REFERENCE RANGE: 11.58-22.52 PMOL/L). THE PHYSICIAN CONSIDERS THE FT4 RESULT ON THE SNIBE ANALYZER TO BE MORE CONSISTENT WITH THE PATIENT'S CLINICAL CONDITION. PATIENT INFORMATION: FEMALE; 30 YEARS OLD. DIAGNOSTICS: BRONCHIAL ASTHMA ATTACK/HYPERTHYROIDISM; THE PATIENT IS NOT TAKING ANY MEDICATION. ADDITIONAL LABORATORY DATA PROVIDED: TSH < 0.0083 UIU/ML PATIENT 2: ON (B)(6) 2026, SID (B)(6) FREE T4 RESULT WAS 14.68. THE PATIENT'S PHYSICIAN QUESTIONED THIS RESULT AND WHEN THE SAMPLE WAS REPEATED THE RESULT WAS 14.81. (ALINITY REFERENCE RANGE IS: 9.01-19.05 PMOL/L.). WHEN TESTED ON THE SNIBE PLATFORM, THE RESULT WAS 25.5 (SNIBE REFERENCE RANGE: 11.58-22.52 PMOL/L). THE PHYSICIAN CONSIDERS THE FT4 RESULT ON THE SNIBE ANALYZER TO BE MORE CONSISTENT WITH THE PATIENT'S CLI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796145 ↗MalfunctionMar 25, 2026High Test Results
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR AN 80-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 9-19 PMOL/L): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6), WAS 47.1, REPEAT RESULT, ON ANOTHER ANALYZER, WAS 17.8 PMOL/L. IT WAS NOTED THAT THE FIRST TIME THE SAMPLE WAS TESTED THERE WAS AN ASPIRATION ERROR. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24686917 ↗MalfunctionMar 25, 2026High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR AN 84-YEAR-OLD FEMALE TAKING WARFARIN DIAGNOSED WITH HEART FAILURE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6) (FREE T4 NORMAL RANGE: 0.70 TO 1.48 NG/DL): FT4 RESULT SERUM SAMPLE = 1.88 NG/DL (RESULT BEING QUESTIONED) REPEAT TESTING AFTER RE-CENTRIFUGING SERUM SAMPLE: FT4 RESULT = 1.39 NG/DL EDTA-K2 PLASMA SAMPLE: FT4 RESULT = 1.27 NG/DL. OTHER TESTING PROVIDED BY THE CUSTOMER: TSH RESULT = 0.8232 UIU/ML, T3 RESULT = < 0.40 NG/ML, BNP RESULT = 395 PG/ML. REPEAT TESTING AFTER RE-CENTRIFUGING SERUM SAMPLE: TSH RESULT = 0.8047 UIU/ML, T3 RESULT = 0.40 NG/ML, EDTA-K2 PLASMA SAMPLE: TSH RESULT = 0.83 UIU/ML, T3 RESULT = < 0.40 NG/ML. THE CUSTOMER STATED THEY ARE ONLY QUESTIONING THE FREE T4 RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24685492 ↗MalfunctionMar 16, 2026High Test Results
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 75-YEAR-OLD FEMALE PATIENT. UPON REPEAT TESTING, THE SAMPLE YIELDED A NORMAL RESULT. IT WAS ALSO NOTED THAT THE PATIENT¿S THYROID RESULTS HAVE BEEN WITHIN NORMAL RANGES FOR THE PAST THREE YEARS. THE FOLLOWING DATA WERE PROVIDED: LAB¿S NORMAL RANGE: 0.70 TO 1.48 NG/DL SID (B)(6): (B)(6) 2026 INITIAL ALINITY I FREE T4 RESULT = >5.00 NG/DL REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 1.33 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604402 ↗MalfunctionMar 4, 2026High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE 76-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 9 TO 19 PMOL/L): SID (B)(6). INITIAL ALINITY I FREE T4 RESULT (B)(6) 2026 WAS 36.2239 PMOL/L. REPEAT MEASUREMENTS FOLLOWING PHYSICIAN COMPLAINT WERE 16.3527 PMOL/L (2:06 PM) AND 16.9720 PMOL/L (2:45 PM). OTHER RESULTS PROVIDED: TSH LEVEL >0.01 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505251 ↗MalfunctionFeb 16, 2026High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULES FOR ONE PATIENT WHICH WAS NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA PROVIDED. (B)(6) MALE, SID (B)(6) , INITIAL RESULT 27.6 PMOL/L, REPEAT RESULT =17.4 PMOL/L ON (B)(6). THE CUSTOMER REFERENCE RANGE: 9.0 TO 19.0 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344769 ↗MalfunctionJan 6, 2026High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE 63-YEAR-OLD FEMALE, HOSPITALIZED FOR ILEUS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SID (B)(6) >5.0 NG/DL, REPEATED >5 NG/DL; SERUM SAMPLE 1.01 NG/DL, (B)(6) 2025 SID (B)(6) >5.0 NG/DL, REPEATED 2.08 / 1.01 / 1.18 / 1.27 / 2.84 / 2.81 NG/DL; SERUM SAMPLE 2.08 NG/DL; TSH 1.71 UIU/ML, FREE T3 2.78 PG/ML. HISTORICAL RESULTS: 31OCT2025 FREE T4 RESULT 1.15 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23979320 ↗MalfunctionDec 23, 2025Low Test Results; Low Test Results
THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I FREE T4 RESULTS FOR A 52-YEAR-OLD MALE PATIENT WHO HAS GRAVES¿ DISEASE. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (AI31369); INITIAL RESULT = < 0.42 NG/DL, REPEAT RESULTS FROM ANOTHER ANALYZER (B)(6): <0.42 NG/DL, PREVIOUS RESULT WAS 1.3 NG/DL. THE CUSTOMER USES REFERENCE RANGE: 0.71-1.51 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879778 ↗MalfunctionNov 6, 2025High Test Results; High Test Results
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED FOR A 77-YEAR-OLD MALE PATIENT SAMPLE DIAGNOSED WITH HYPOTHYROIDISM. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 19.75 PMOL/L, REPEAT RESULTS = 16.59 PMOL/L, 16.62 PMOL/L. OTHER RESULTS PROVIDED THAT THE CUSTOMER IS NOT QUESTIONING: TSH INITIAL RESULT = 0.7698 UIU/ML, REPEAT RESULT = 0.7712 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485280 ↗MalfunctionOct 15, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED FALSE ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025 INITIAL RESULT WAS > 5.0 NG/DL, ON (B)(6) 2025 INITIAL RESULT WAS > 5.0 NG/DL, ON (B)(6) 2025 INITIAL RESULT WAS 1.33 NG/DL, ON (B)(6) 2025 INITIAL RESULT WAS > 5.0 NG/DL. ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT WAS > 5.0 NG/DL AND RETEST RESULT WAS 1.32 NG/DL. FREE T4 WAS MEASURED AT ANOTHER INSTITUTION ON THE COBAS PLATFORM, AND THE RESULT WAS WITHIN THE REFERENCE RANGE. ADDITIONALLY, CUSTOMER REPORTED ABNORMAL FINDINGS IN THE TEST RESULTS FOR BIOCHEMISTRY, BLOOD COUNTS, OR THYROID AUTOANTIBODIES, ETC. PATIENT INFORMATION: 77-YEAR-OLD MALE MEDICAL HISTORY: COLON EMR, ATRIAL FIBRILLATION, HYPERTENSION, DIABETES MEDICATION: MERCAZOLE, IODINE, AMLODOPINE, ONGLYZA, LIXIANA, ASTOMIN (MMT IS CURRENTLY ON PAUSE) THE CUSTOMER REPORTED THAT THE PATIENT HAS BEEN RECEIVING TREATMENT (DETAILS NOT PROVIDED) AND THE CUSTOMER DOESN'T FEEL THAT THE TREATMENT THE PATIENT HAS BEEN RECEIVING HAS BEEN UNNECESSARY. OTHER THYROID TEST RESULTS (E.G., TSH): WITHIN REFERENCE RANGE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER SENT THE SAMPLE OUT FOR ADDITIONAL TESTING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23284622 ↗MalfunctionOct 7, 2025Low Test Results; Low Test Results
THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I FREE T4 RESULTS FOR 34-YEAR-OLD PATIENT FEMALE PATIENT DIAGNOSED WITH THYROTOXICOSIS AND IS CURRENTLY UNDERGOING TREATMENT. THE FOLLOWING RESULTS WERE PROVIDED: (NORMAL RANGE: 9.01 - 19.05 PMOL/L) ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT = 18.58 PMOL/L, REPEAT RESULT = 18.68 PMOL/L, RESULT ON ROCHE COBAS = 28.92 PMOL/L (NORMAL RANGE: 12-22 PMOL/L) HISTORICAL RESULTS ON A DIFFERENT ANALYZER FREE T4 RESULT = 50.7 PMOL/L RESULTS FROM (B)(6) 2025 ON ALINITY FREE T4 RESULT = 42.77 PMOL/L ADDTIIONAL LAB RESULTS: TSH = < 0.0083 UIU/ML, FREE T3 = 9.170 PMOL/L, TRAB = 6.590 IU/L HISTORICAL RESULTS ON A DIFFERENT ANALYZER: TSH = 0.005 UIU/ML FREE T3 = 23.6 PMOL/L TRAB = 8.68 IU/L ANTI-TPO = 20.3 IU/ML RESULTS FROM (B)(6) 2025 ON ALINITY WITH REFERENCE RANGES: TSH = <0.0083 UIU/ML (0.350 - 4.940 UIU/ML) FREE T3 = >30.72 PMOL/L (2.427-6.006 PMOL/L) TRAB = 6.77 IU/L (<3.100 IU/L) ANTI-TPO = 13.9 IU/ML (< 5.61 IU/ML) THE CUSTOMER MENTIONED THEY ARE ONLY QUESTIONING THE FREE T4 RESULTS AS BEING INCORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23232497 ↗MalfunctionOct 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER OBSERVED ERRATIC ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9 - 19 PMOL/L): (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 7.8 PMOL/L; REPEAT RESULT= 11.7 PMOL/L, (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 33.2 PMOL/L; REPEAT RESULT= 12.1 PMOL/L, (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 27.8 PMOL/L; REPEAT RESULT= 18.8 PMOL/L, (B)(6) 2025, SID(B)(6) , INITIAL FT4 RESULT (B)(6)= 35.8 PMOL/L; REPEAT RESULT= 15.4 PMOL/L, (B)(6) 2025, SID(B)(6) , INITIAL FT4 RESULT (B)(6)= 29.9 PMOL/L; REPEAT RESULT= 16 PMOL/L, (B)(6) 2025, SID(B)(6) , INITIAL FT4 RESULT (B)(6)= 25 PMOL/L; REPEAT RESULT= 18.6 PMOL/L, (B)(6) 2025, SID(B)(6) , INITIAL FT4 RESULT (B)(6)= 24.9 PMOL/L; REPEAT RESULT= 17.9 PMOL/L, (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 65 PMOL/L; REPEAT RESULT= 17.3 PMOL/L. (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 29.2 PMOL/L; REPEAT RESULT= 17 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23200099 ↗MalfunctionSep 30, 2025Low Test Results; Low Test Results
THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I FREE T4 RESULTS FOR AN 83-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 INITIAL FREE T4 (B)(6) 2025) 1.21, REPEATED (B)(6) 2025) 1.78. HISTORICAL RESULTS: FREE T4 ((B)(6) 2025) 1.49, (B)(6) 2025) 1.3, (B)(6) 2024) 1.57, (B)(6) 2024) 1.44, (B)(6) 2024) 1.35, (B)(6) 2024) 2.72, (B)(6) 2023) 1.97, (B)(6) 2023) 1.24 AND 1.2, (B)(6) 2023) 1.34, (B)(6) 2022) 1.67 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23179691 ↗MalfunctionSep 29, 2025High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I FREE T4 RESULTS. SID (B)(6) GENERATED >5 NG/DL, REPEATED 1.26 NG/DL, REPEATED 1.98 NG/DL, REPEATED 0.99 NG/DL. NORMAL RANGE 0.7-1.48 NG/DL. THE CUSTOMER DOES NOT HAVE FURTHER INFORMATION ABOUT THE PATIENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23173337 ↗MalfunctionSep 26, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE USED BY THE CUSTOMER IS 0.70 TO 1.48 NG/DL): ON (B)(6) 2024: INITIAL RESULT = 2.45 NG/DL, REPEAT = 1.07 NG/DL. ON (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = >5 NG/DL, REPEAT ON NOVEMBER 07 = 0.92 NG/DL. ON (B)(6): INITIAL RESULT = 2.2 NG/DL, REPEAT = 1.22 NG/DL. ON (B)(6): INITIAL RESULT = 1.53 NG/DL, REPEAT = 1.34 NG/DL. ON (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.11 NG/DL. ON (B)(6) 2025: INITIAL RESULT = 1.64 NG/DL, REPEAT = 1.09 NG/DL. ON (B)(6): INITIAL RESULT = 2.17 NG/DL, REPEAT = 1.35 NG/DL. ON (B)(6): INITIAL RESULT = 5 NG/DL, REPEAT = 3.77 NG/DL. ON (B)(6) (SECOND): INITIAL RESULT = 1.94 NG/DL, REPEAT = 1.20 NG/DL. ON (B)(6): INITIAL RESULT = 1.50 NG/DL, REPEAT = 1.33 NG/DL. ON (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.36 NG/DL. ON (B)(6): INITIAL RESULT = 1.69 NG/DL, REPEAT = 1.43 NG/DL. ON (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.76 NG/DL. ON (B)(6): INITIAL RESULT = 1.72 NG/DL, REPEAT = 1.46 NG/DL. ON (B)(6): INITIAL RESULT = 1.62 NG/DL, REPEAT = 1.13 NG/DL. ON (B)(6): INITIAL RESULT = 1.52
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23154263 ↗MalfunctionSep 26, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE USED BY THE CUSTOMER IS 0.70 TO 1.48 NG/DL): ON (B)(6) 2024: INITIAL RESULT = 2.45 NG/DL, REPEAT = 1.07 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = >5 NG/DL, REPEAT ON (B)(6) = 0.92 NG/DL. (B)(6): INITIAL RESULT = 2.2 NG/DL, REPEAT = 1.22 NG/DL. (B)(6): INITIAL RESULT = 1.53 NG/DL, REPEAT = 1.34 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.11 NG/DL. (B)(6) 2025: INITIAL RESULT = 1.64 NG/DL, REPEAT = 1.09 NG/DL. (B)(6): INITIAL RESULT = 2.17 NG/DL, REPEAT = 1.35 NG/DL. (B)(6): INITIAL RESULT = 5 NG/DL, REPEAT = 3.77 NG/DL. (B)(6) (SECOND): INITIAL RESULT = 1.94 NG/DL, REPEAT = 1.20 NG/DL. (B)(6): INITIAL RESULT = 1.50 NG/DL, REPEAT = 1.33 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.36 NG/DL. (B)(6): INITIAL RESULT = 1.69 NG/DL, REPEAT = 1.43 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.76 NG/DL. (B)(6): INITIAL RESULT = 1.72 NG/DL, REPEAT = 1.46 NG/DL. (B)(6): INITIAL RESULT = 1.62 NG/DL, REPEAT = 1.13 NG/DL. (B)(6): INITIAL RESULT = 1.52 NG/DL, REPEAT = 1.11 NG/DL. (B)(6): INITIAL RESUL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23154262 ↗MalfunctionSep 26, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE USED BY THE CUSTOMER IS 0.70 TO 1.48 NG/DL): (B)(6) 2024: INITIAL RESULT = 2.45 NG/DL, REPEAT = 1.07 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = >5 NG/DL, REPEAT ON (B)(6) = 0.92 NG/DL, (B)(6): INITIAL RESULT = 2.2 NG/DL, REPEAT = 1.22 NG/DL, (B)(6): INITIAL RESULT = 1.53 NG/DL, REPEAT = 1.34 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.11 NG/DL, (B)(6) 2025: INITIAL RESULT = 1.64 NG/DL, REPEAT = 1.09 NG/DL, (B)(6): INITIAL RESULT = 2.17 NG/DL, REPEAT = 1.35 NG/DL, (B)(6): INITIAL RESULT = 5 NG/DL, REPEAT = 3.77 NG/DL, (B)(6) (SECOND): INITIAL RESULT = 1.94 NG/DL, REPEAT = 1.20 NG/DL, (B)(6): INITIAL RESULT = 1.50 NG/DL, REPEAT = 1.33 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.36 NG/DL, (B)(6): INITIAL RESULT = 1.69 NG/DL, REPEAT = 1.43 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.76 NG/DL, (B)(6): INITIAL RESULT = 1.72 NG/DL, REPEAT = 1.46 NG/DL, (B)(6): INITIAL RESULT = 1.62 NG/DL, REPEAT = 1.13 NG/DL, (B)(6): INITIAL RESULT = 1.52 NG/DL, REPEAT = 1.11 NG/DL, (B)(6): INITIAL RESULT =
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23154199 ↗MalfunctionSep 26, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE USED BY THE CUSTOMER IS 0.70 TO 1.48 NG/DL): ON (B)(6) 2024: INITIAL RESULT = 2.45 NG/DL, REPEAT = 1.07 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = >5 NG/DL, REPEAT ON (B)(6) = 0.92 NG/DL, (B)(6): INITIAL RESULT = 2.2 NG/DL, REPEAT = 1.22 NG/DL, (B)(6): INITIAL RESULT = 1.53 NG/DL, REPEAT = 1.34 NG/DL, (B)(6) : INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.11 NG/DL, (B)(6) 2025: INITIAL RESULT = 1.64 NG/DL, REPEAT = 1.09 NG/DL, (B)(6): INITIAL RESULT = 2.17 NG/DL, REPEAT = 1.35 NG/DL, (B)(6): INITIAL RESULT = 5 NG/DL, REPEAT = 3.77 NG/DL, (B)(6) (SECOND): INITIAL RESULT = 1.94 NG/DL, REPEAT = 1.20 NG/DL, (B)(6): INITIAL RESULT = 1.50 NG/DL, REPEAT = 1.33 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.36 NG/DL, (B)(6): INITIAL RESULT = 1.69 NG/DL, REPEAT = 1.43 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.76 NG/DL, (B)(6): INITIAL RESULT = 1.72 NG/DL, REPEAT = 1.46 NG/DL, (B)(6): INITIAL RESULT = 1.62 NG/DL, REPEAT = 1.13 NG/DL, (B)(6): INITIAL RESULT = 1.52 NG/DL, REPEAT = 1.11 NG/DL, (B)(6): INITIAL RESU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23154198 ↗MalfunctionSep 26, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE USED BY THE CUSTOMER IS 0.70 TO 1.48 NG/DL): (B)(6) 2024: INITIAL RESULT = 2.45 NG/DL, REPEAT = 1.07 NG/DL (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT WAS >5 NG/DL, REPEAT ON NOVEMBER 07 = 0.92 NG/DL (B)(6): INITIAL RESULT = 2.2 NG/DL, REPEAT = 1.22 NG/DL (B)(6): INITIAL RESULT = 1.53 NG/DL, REPEAT = 1.34 NG/DL (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.11 NG/DL (B)(6), 2025: INITIAL RESULT = 1.64 NG/DL, REPEAT = 1.09 NG/DL (B)(6): INITIAL RESULT = 2.17 NG/DL, REPEAT = 1.35 NG/DL (B)(6): INITIAL RESULT = 5 NG/DL, REPEAT = 3.77 NG/DL (B)(6): (SECOND): INITIAL RESULT = 1.94 NG/DL, REPEAT = 1.20 NG/DL (B)(6): INITIAL RESULT = 1.50 NG/DL, REPEAT = 1.33 NG/DL (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.36 NG/DL (B)(6): INITIAL RESULT = 1.69 NG/DL, REPEAT = 1.43 NG/DL (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.76 NG/DL (B)(6): INITIAL RESULT = 1.72 NG/DL, REPEAT = 1.46 NG/DL (B)(6): INITIAL RESULT = 1.62 NG/DL, REPEAT = 1.13 NG/DL (B)(6): INITIAL RESULT = 1.52 NG/DL, REPEAT = 1.11 NG/DL (B)(6): INITIAL RESULT = 1.92 N
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23154140 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.