Alinity 07P4830Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00380740131159), received between Nov 21, 2018 and Sep 21, 2026 — classified as 91 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (61 reports).

2 FDA recall records 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-0664-2019 · Root cause: Nonconforming Material/Component · FDA record ↗

2. 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-0667-2019 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Low Test Results

  The customer reported falsely depressed Alinity i TSH results for three patients. The samples were repeated with higher results. The following data was provided:Initial Results:Sample id: (b)(6) : < 0.0083 mIU/mL,Sample id: (b)(6) : <0.0131 mIU/mL,Sample id: (b)(6) : < 0.0083 mIU/mL.Rerun results:Sample id:(b)(6): 1.3704 mIU/mL,Sample id:(b)(6) : 3.7146 mIU/mL,Sample id:(b)(6) : 0.8114 mIU/mL There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842562 ↗
• MalfunctionSep 14, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763314 ↗
• MalfunctionApr 16, 2026Imprecise or Erratic Results

  THE CUSTOMER OBSERVED DISCREPANT ALINITY I TSH RESULTS GENERATED FOR AN 82-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMERS REFERENCE RANGE 0.35 UIU/ML TO 4.94 UIU/ML): SAMPLE ID (B)(6): (B)(6) 2026 INITIAL RESULT IN LITHIUM HEPARIN PLASMA TUBE = 0.14 MIU/L, (B)(6) 2026 REPEAT RESULT = 0.07 MIU/L. SAME PATIENT: (B)(6) 2026 RESULT IN SERUM GEL SEPARATOR TUBE = 0.79 MIU/L, (B)(6) 2026 REPEAT RESULT = 0.83 MIU/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894923 ↗
• MalfunctionFeb 25, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 0.4 TO 4.5 UIU/ML): (B)(6) 2026, SID (B)(6), INITIAL RESULT 0.0164 UIU/ML, REPEATED ON (B)(6) 2026 1.738 MIU/ML. (B)(6) 2026, SID (B)(6), INITIAL RESULT <0.01 UIU/ML, RECOLLECTED A NEW SAMPLE ON (B)(6) 2026 SID (B)(6), RESULT WAS 1.728 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442205 ↗
• MalfunctionFeb 17, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH RESULTS FOR A 49-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0.35-4.0 MIU/ML): SID (B)(6) INITIAL RESULT (B)(6) 2026 WAS 3.48 MIU/ML, THE SAMPLE WAS REPEATED ON (B)(6) 2026 AND THE RESULT WAS 1.73 MIU/ML THE PATIENTS¿ HISTORICAL RESULTS FROM (B)(6) 2025 3.39 MIU/ML AND (B)(6) 2025 4.54 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369352 ↗
• MalfunctionFeb 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED INCONSISTENT ALINITY I TSH RESULTS. CUSTOMER REFERENCE RANGE TSH: 0.35 TO 4.94 UIU/L. EXAMPLES WERE PROVIDED: CASE 1 (MALE PATIENT): ON (B)(6) 2025, ID (B)(6) USING SERIAL (B)(6), GENERATED TSH OF 6.305 UIU/L. ON (B)(6) 2025, ID (B)(6) USING SERIAL (B)(6), GENERATED TSH OF 2.016 UIU/L. ADDITIONAL TESTING OF TOTAL T3 AND TOTAL T4 WERE PROCESSED WITH VALUES IN THE NORMAL RANGE. ON (B)(6) 2026, ID (B)(6), USING SERIAL (B)(6), GENERATED TSH OF 4.66 UIU/L. ADDITIONAL TESTING OF TOTAL T3, TOTAL T4, FREE T3, AND FREE T4 WERE PROCESSED WITH ALL ANALYTES IN THE NORMAL RANGE. CASE 2 (FEMALE PATIENT): ON (B)(6) 2026, ID (B)(6) USING SERIAL (B)(6), GENERATED TSH OF 3.139 UIU/L. ON (B)(6) 2026, ID (B)(6), ON SAME SERIAL, GENERATED TSH OF 7.034 UIU/L WAS OBTAINED. CASE 3 (FEMALE PATIENT): ON (B)(6) 2025, ID (B)(6) USING SERIAL (B)(6), GENERATED TSH 2.863 UIU/L. ADDITIONAL TESTING OF FREE T4 WAS PROCESSED WITH VALUE IN THE NORMAL RANGE. ON (B)(6) 2025, ID (B)(6) USING SERIAL (B)(6), GENERATED TSH OF 11.031 UIU/L. CASE 4 (FEMALE PATIENT): ON (B)(6) 2025, ID (B)(6) USING SERIAL (B)(6) GENERATED TSH OF 0.4785 UIU/L. ADDITIONAL TESTING OF TOTAL T3, AND FREE T4 WERE PROCESSED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317186 ↗
• MalfunctionJan 29, 2026High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ALINITY I TSH FOR ONE FEMALE PATIENT BORN IN 1995. A NEW SAMPLE FROM THE SAME PATIENT HAD LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON (B)(6) 2025 REAGENT LOT 79194UD00: ALINITY I SERIAL NUMBER (B)(6) RESULT = 276.491 AND >100.000 ALINITY I SERIAL NUMBER (B)(6) RESULT = 271.368. SID (B)(6) PROCESSED ON (B)(6) 2026 REAGENT LOT 80653UD00 ON ALINITY I SERIAL NUMBER (B)(6) = 2.483. CUSTOMER¿S TSH REFERENCE RANGE = 0.4-4.0 ME/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209404 ↗
• MalfunctionDec 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I TSH RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULTS (B)(6) / RECOLLECT/REDRAW RESULTS (B)(6): SN# (B)(6) SID (B)(6), MALE 71 YR INITIAL / RETEST: 0.110 / 6.99 SN# (B)(6) SID (B)(6), MALE 62 YR INITIAL / RETEST: 0.270 / 5.22 SIDS (B)(6) WERE BOTH <1.0 ON INITIALS TSH REFERENCE RANGE: 0.35-4.94 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866126 ↗
• MalfunctionDec 9, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DEPRESSED ALINITY I TSH RESULTS COMPARED WITH ANOTHER METHOD. SID: (B)(6). ON (B)(6) 2025 ALINITY I TSH 3.8204 UIU/ML (REFERENCE RANGE 0.35-4.94 UIU/ML). ON (B)(6) 2025 ALINITY I TSH 4.0845 UIU/ML (REFERENCE RANGE 0.35-4.94 UIU/ML). ON (B)(6) 2025 CLIA CENTAUR METHOD 14.457 UIU/ML (REFERENCE RANGE 0.55-4.78 UIU/ML). TOTAL T3 AND TOTAL T4 ARE NORMAL. PER THE PATIENT, THERE IS NO CLINICAL HISTORY OR ON ANY MEDICATION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758274 ↗
• MalfunctionDec 4, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TSH RESULTS FOR A 64-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) RESULT, ON (B)(6) 2025, WAS 4.3879 UIU/ML. THE PATIENT WAS PREVIOUSLY TESTED ON (B)(6) 2025, AND THE RESULT WAS 10.69 UIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717704 ↗
• MalfunctionNov 5, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH RESULTS FOR A 32-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). ALINITY I TSH RESULT (B)(6) 2025 INITIAL RESULT 4.236 MIU/L, REPEATED 4.05 MIU/L. ROCHE RESULT ON (B)(6) 2025 WAS 96.20 UIU/ML. (B)(6) HOSPITAL ROCHE RESULT 16OCT2025 = >100.0 UIU/ML. BECKMAN COULTER RESULT WAS 101.63 UIU/ML. A NEW SAMPLE WAS OBTAINED, AND THE ALINITY I TSH RESULTS WERE 3.0570 AND 3.0415 MIU/L. OTHER RESULTS PROVIDED: TOTAL T3: 0.69 TOTAL T4: 2.93 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477881 ↗
• MalfunctionSep 15, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I THYROID STIMULATING HORMONE (TSH) RESULT FOR ONE PATIENT. THE SAMPLE WAS HIGHER BY ANOTHER METHOD. THE FOLLOWING DATA PROVIDED: SID (B)(6), ALINITY TSH RESULT = 3.01 REFERENCE RANGE = 0.37-4.4 UIU/ML. ROCHE RESULT (OTHER LAB) = 5.2 AND 5.1 REFERENCE RANGE = 0.27-4.2 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051810 ↗
• MalfunctionJul 29, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSE DECREASED ALINITY I TSH AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) WAS PROCESSED ON ALINITY I ANALYZER (SN: (B)(6). THE INITIAL RESULT WAS <0.008 MIU/L AND REPEAT RESULTS WERE 0.019 MIU/L & 0.355 MIU/L. CUSTOMER REFERENCE RANGE: 0.35 - 4.94 MIU/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 22649780 ↗
• MalfunctionJul 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I TSH RESULTS FOR THREE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.35-4.94 MIU/L): SAMPLE ID: (B)(6) INITIAL RESULT, ON (B)(6) 2025, WAS <0.008, REPEAT RESULTS WERE 0.239 AND 0.308 MIU/L. SAMPLE ID: (B)(6) INITIAL RESULT, ON (B)(6) 2025, WAS 0.139, REPEAT RESULTS WERE 0.078 AND 5.673 MIU/L. SAMPLE ID: (B)(6) INITIAL RESULT, ON (B)(6) 2025, WAS 0.016, REPEAT RESULTS WERE 0.131 AND 4.135 MIU/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543111 ↗
• MalfunctionJun 23, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). RESULT FROM (B)(6) 2025 WAS 0.054 MIU/L. RETESTED (B)(6) 2025 AND THE RESULT WAS 18.541 MIU/L. SID (B)(6). INITIAL RESULT FROM (B)(6) 2025 WAS 0.033 MIU/L, REPEATED THE SAMPLE ON THE SAME DAY AND THE REPEAT RESULTS WERE 8.785 AND 8.747 MIU/L. CUSTOMER TSH REFERENCE RANGE: 0.35 - 4.94 MIU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310427 ↗
• MalfunctionMay 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I TSH AND PROVIDED THE FOLLOWING DATA: THE PATIENT HAS HAD ELEVATED TSH RESULTS. ON (B)(6), THE PATIENT WAS TESTED FOR TSH WHILE IN (B)(6) AND GENERATED A RESULT OF 1.714 MIU/L (PLATFORM UNKNOWN). ON (B)(6) 2025, THE FACILITY THAT THE PATIENT IS NORMALLY TESTED AT GENERATED A RESULT OF 5.85 MIU/L. ON (B)(6) 2025, THE PATIENT WENT TO ANOTHER FACILITY AND THE TSH RESULT ON THE CENTAUR PLATFORM WAS 2.54 MIU/L ON (B)(6) 2025, A NEW SAMPLE WAS TESTED ON ALINITY PLATFORM, WHICH GENERATED A RESULT OF 4.61 MIU/L AND ARCHITECT PLATFORM GENERATED A RESULT OF 4.7 MIU/L. PACKAGE INSERT NORMAL RANGE IS 0.35 IU/ML TO 4.94 MIU/L. HISTORICAL TSH RESULTS: ON (B)(6) 2025 WITH ANALYZER (B)(6) THE RESULT WAS 5.85. ON (B)(6) 2025 WITH ANALYZER (B)(6) THE RESULT WAS 7.37. ON (B)(6) 2025 WITH ANALYZER (B)(6) THE RESULT WAS 5.64. ON (B)(6) 2025 WITH ANALYZER (B)(6) THE RESULT WAS 4.8. ON (B)(6) 2025 WITH ANALYZER (B)(6) THE RESULT WAS 5.12. ON (B)(6) 2025 WITH ANALYZER (B)(6) THE RESULT WAS 5.74. ON (B)(6) 2024 WITH ANALYZER (B)(6) THE RESULT WAS 4.17. PATIENT INFORMATION: FEMALE PATIENT WAITING TO START IVF. HER PHYSICIAN HAS NOT STARTED DUE TO ELEVATED TSH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114237 ↗
• MalfunctionMay 25, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ALINITY I TSH AND PROVIDED THE FOLLOWING DATA: THE FIRST SAMPLE (SAMPLE ID (B)(6) WAS HEMOLYZED AND GENERATED A RESULT OF 5.1393 MIU/ML. THE CUSTOMER REQUESTED A NEW SAMPLE, WHICH GENERATED A RESULT OF 3.8111 MIU/ML. THE HEMOLYZED SAMPLE WAS THEN REPEATED AND GENERATED A RESULT OF 5.3163 MIU/ML. (CUSTOMER REFERENCE RANGE 0.35 - 4.94 MIU/ML). PER THE CUSTOMER THE DISCREPANT RESULT(S) WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082923 ↗
• MalfunctionMay 6, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I TSH RESULTS ON A PATIENT SAMPLE. ON (B)(6) 2025 SID (B)(6) (MALE PATIENT) GENERATED ALINITY I TSH OF 7.83 IU/ML. DIFFERENT SAMPLES OBTAINED FROM THE SAME PATIENT GENERATED ALINITY I TSH OF 3.52 IU/ML ((B)(6) 2025) AND 4.06 IU/ML ((B)(6) 2025). THE CUSTOMER TSH NORMAL RANGE IS 0.35 TO 4.94 IU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973198 ↗
• MalfunctionApr 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TSH RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.35-4.94 MIU/L): SAMPLE ID (B)(6) INITIAL RESULT, ON 28MAR2025 WITH ANALYZER SERIAL NUMBER (B)(6), WAS 0.273, REPEAT RESULT, ON 31MAR2025 WITH ANALYZER SERIAL NUMBER (B)(6), WAS 34.642 MIU/L. SAMPLE ID (B)(6) INITIAL RESULT, ON 29MAR2025 WITH ANALYZER SERIAL NUMBER (B)(6), WAS 1.523, REPEAT RESULT, ON 31MAR2025, WAS 39.067 MIU/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901189 ↗
• MalfunctionApr 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY LOW ALINITY I TSH. THE CUSTOMER REPORTED THAT THE RESULTS ARE LOW WHEN COMPARED TO ROCHE AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: UNDILUTED = 0.06, AUTO DIL 1:5 = 0.259, MAN DIL 1:10 = 0.388, PEG DIL 1:2 = 0.127. CUSTOMER REFERENCE RANGE: 6 M - 13 Y : 0.7 - 4.2 IU/ML. 14 - 74 Y : 0.4 - 3.3 IU/ML. > 74 Y: 0.4 - 4.0 IU/ML. RESULTS FROM ROCHE WAS 1.0 IU/ML. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21793804 ↗
• MalfunctionApr 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TSH RESULTS ON A PATIENT DIAGNOSED WITH HYPERTHYROID. THE RESULTS PROVIDED WERE: ON (B)(6) 2024, SID (B)(6) =7.87 MIU/L . ON (B)(6) 2024, SKTNHR ON ROCHE=< 0.01 MIU/L. ON (B)(6) 2024, SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025 AT SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025, ON ROCHE=0.267 MIU/L /ON BECKMAN=0.305 MIU/L. LABORATORY REFERENCE RANGE FOR ALINITY TSH=0.35 TO 4.94 MIU/L; ROCHE=0.27 TO 4.2 MIU/L; BECKMAN=0.30 TO 5.50 MIU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21792318 ↗
• MalfunctionApr 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TSH RESULTS ON A PATIENT DIAGNOSED WITH HYPERTHYROID. THE RESULTS PROVIDED WERE: ON (B)(6)2024, SID (B)(6) =5.26 MIU/L. ON (B)(6) 2024, SKTNHR ON ROCHE=< 0.01 MIU/L. ON (B)(6) 2024, SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025, AT SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025, ON ROCHE=0.267 MIU/L /ON BECKMAN=0.305 MIU/L. LABORATORY REFERENCE RANGE FOR ALINITY TSH=0.35 TO 4.94 MIU/L; ROCHE=0.27 TO 4.2 MIU/L; BECKMAN=0.30 TO 5.50 MIU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21791771 ↗
• MalfunctionApr 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TSH RESULTS ON A PATIENT DIAGNOSED WITH HYPERTHYROID. THE RESULTS PROVIDED WERE: ON (B)(6) 2024, SID (B)(6) =5.48 MIU/L. ON (B)(6) 2024, SID (B)(6) =6.82 MIU/L. PREVIOUS HISTORY ON (B)(6) 2024 SKTNHR ON ROCHE=< 0.01 MIU/L. ON (B)(6) 2024, SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025, AT SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025, ON ROCHE=0.267 MIU/L /ON BECKMAN=0.305 MIU/L. LABORATORY REFERENCE RANGE FOR ALINITY TSH=0.35 TO 4.94 MIU/L; ROCHE=0.27 TO 4.2 MIU/L; BECKMAN=0.30 TO 5.50 MIU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21791137 ↗
• MalfunctionApr 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TSH RESULTS ON A PATIENT DIAGNOSED WITH HYPERTHYROID. THE RESULTS PROVIDED WERE: ON (B)(6) 2024, SID (B)(6) =8.36 MIU/L. ON (B)(6) 2024, SID (B)(6) =8.32 MIU/L . PREVIOUS HISTORY ON (B)(6) 2024 SKTNHR ON ROCHE=< 0.01 MIU/L. ON (B)(6) 2024 SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025 AT SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025 ON ROCHE=0.267 MIU/L /ON BECKMAN=0.305 MIU/L. LABORATORY REFERENCE RANGE FOR ALINITY TSH=0.35 TO 4.94 MIU/L; ROCHE=0.27 TO 4.2 MIU/L; BECKMAN=0.30 TO 5.50 MIU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21790381 ↗
• MalfunctionApr 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TSH RESULTS ON A PATIENT DIAGNOSED WITH HYPERTHYROID. THE RESULTS PROVIDED WERE: ON (B)(6) 2025, SID (B)(6) TSH ON (B)(6) =5.86 MIU/L /ON (B)(6) 2025 AND (B)(6) =5.54 MIU/L. PREVIOUS HISTORY ON (B)(6) 2024 SKTNHR ON ROCHE=< 0.01 MIU/L. ON (B)(6) 2024 SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025 AT SKTNHR ON ROCHE=0.03 MIU/L. ON (B)(6) 2025 ON ROCHE=0.267 MIU/L /ON BECKMAN=0.305 MIU/L. LABORATORY REFERENCE RANGE FOR ALINITY TSH=0.35 TO 4.94 MIU/L; ROCHE=0.27 TO 4.2 MIU/L; BECKMAN=0.30 TO 5.50 MIU/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21788865 ↗