ARCHITECT 7K62-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00380740014230), received between Nov 18, 2016 and Jan 26, 2026 — classified as 94 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (85 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 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT TSH RESULT FOR ONE FEMALE PATIENT IN HER EIGHTIES WHO IS NOT ON ANY THYROID TREATMENT WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: PATIENT ARCHITECT RESULTS FROM (B)(6) 2025: TSH 3.16 UIU/ML OTHER RESULTS = FT3 2.75 PG/ML FT4 2.10 NG/DL. PATIENT RESULTS FROM ANOTHER METHOD(CLEIA): TSH 7.10 UIU/ML OTHER RESULTS = FT3 2.60 PG/ML FT4 0.97 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180089 ↗
• MalfunctionNov 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A DISCREPANT ARCHITECT TSH RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) SERUM = 2.9497 / 2.8832 / 3.2478 UIU/ML, PLASMA = 8.3296 UIU/ML; PREVIOUS RESULT FROM (B)(6) 2025 = 10.61 UIU/ML REFERENCE RANGE: 0.3-4.2 UIU/ML. THE PATIENT HAD THEIR THYROID MEDICATION TEMPORARILY DELAYED DUE TO THE LOW FALSELY LOW TSH RESULT. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497566 ↗
• MalfunctionAug 11, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TSH RESULT GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER'S REFERENCE RANGE: 0.35 IU/ML TO 4.94 IU/ML. SID (B)(6): INITIAL TSH RESULT = 9.0642 IU/ML; REPEAT RESULT = 4.189 IU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769452 ↗
• MalfunctionJun 26, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TSH FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE TSH 0.5-5 UIU/ML): ON (B)(6) 2025, SID: (B)(6), TSH RESULT= 4.95 UIU/ML; HISTORY OF TSH RESULTS= 0.06 - 0.07 UIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337164 ↗
• MalfunctionJun 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE ARCHITECT THYROID STIMULATING HORMONE (TSH) RESULTS ON MULTIPLE PATIENTS. THE RESULT PROVIDED WERE: ON (B)(6) 2025 PATIENT 1: SID (B)(6) INITIAL= 0.21 MIU/L /REPEATED=1.45 MIU/L /REDRAWN AND REPEATED FROM SAME PATIENT SID (B)(6) =1.79 MIU/L. PATIENT 2: SID (B)(6) INITIAL=8.93 IU/ML /REPEATED=0.87 MIU/L. LABORATORY REFERENCE RANGE FOR TSH=0.35 TO 4.94 MIU/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184020 ↗
• MalfunctionApr 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ARCHITECT TSH RESULT 1.7 AND 1.76 IU/ ML, REPEATED 1.74 IU/ ML AND 1.7957 UIU/ML AND 1.7417 UIU/ML. THE CUSTOMER RETESTED THE SAMPLE ON DIFFERENT ABBOTT EQUIPMENT AS WELL, AND THE VALUE OBTAIN WAS 1.7563 UIU/ML. SAME SAMPLE TESTED ON BECKMAN COULTER ANALYZER RESULT REPORTED 7.53 IU/ ML AND ROCHE REPORTED 8.990 IU/ ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876198 ↗
• MalfunctionJan 30, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) RESULT WAS 4.7389UIU/ML. WHEN TESTED ON MINDRAY PLATFORM THE RESULT WAS 8UIU/ML AND WHEN TESTED ON ROCHE PLATFORM THE RESULT WAS 10.460UIU/ML. PATIENT DATA: 1 DAY OLD PATIENT. 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 21278120 ↗
• MalfunctionJan 16, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT TSH FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE TSH 0.35-4.94 UIU/ML): SID (B)(6) , (B)(6) 2024, INITIAL TSH RESULT= 7.02 UIU/ML; (B)(6) 2024, REPEAT TSH RESULT= 3.52 UIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170359 ↗
• MalfunctionDec 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2024 ARCHITECT = 4.26, ROCHE = 22.50; REPEATED SAMPLE ON (B)(6) 2024 ARCHITECT = 4.89, ROCHE = 35.84; ANOTHER LABORATORY (ECLIA = 38.20). ARCHITECT TSH NORMAL RANGE: 0.35-4.94 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025753 ↗
• MalfunctionDec 23, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR A PREMATURE INFANT BABY WHO¿S MOTHER HAS A HISTORY OF HYPOTHYROIDISM. THE FOLLOWING DATA WAS PROVIDED: ABBOTT REFERENCE RANGE: 0.35 TO 4.94 UIU/ML, ROCHE COBAS REFERENCE RANGE: 0.35 TO 4.94 UIU/ML ON (B)(6) 2024, SID: (B)(6): ISR60121 = 0.177 UIU/ML, REPEAT = 15.169 UIU/ML, ROCHE COBAS = 32.11 UIU/ML, REPEAT = 31.27 UIU/ML ON (B)(6) 2024, SAMPLE (B)(6): ISR60121 = 0.310 UIU/ML, REPEAT = 12.907 UIU/ML, ROCHE COBAS = 20.66 UIU/ML ADDITIONAL LABORATORY DATA PROVIDED: TRAB RESULT = 0.8 IU/L (NORMAL RANGE: <1.75 IU/L), FT3 = 1.18 NMOL/L (NORMAL RANGE: 1.30 TO 3.10 NMOL/L), FT4 = 17.2 PMOL/L (NORMAL RANGE: 12 TO 22 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21003028 ↗
• MalfunctionDec 20, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TSH RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 SID (B)(6) INITIAL TSH=3.44 UIU/ML /REPEATED=2.78 AND 4.58 UIU/ML. FT4 INITIAL=3.07 NG/DL /REPEATED=1.19 NG/DL AND 1.04 NG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20990332 ↗
• MalfunctionDec 9, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TSH RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). (B)(6) 2024 INITIAL TSH RESULT 6.22 UIU/ML, REPEATED 4.96 UIU/ML. PREVIOUS VALUE 1.547 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880446 ↗
• MalfunctionSep 10, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.35-4.94 UIU/ML): INITIAL RESULT, ON 07AUG, WAS 0.0, REPEAT, AFTER RE-CENTRIFUGING, WAS 1.16, REPEAT WAS 0.01 UIU/ML. THE PATIENT WAS SENT TO ANOTHER HOSPITAL AND WAS TESTED ON (B)(6) AND THE RESULT, ON AN UNKNOWN PLATFORM, WAS 1.8. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185067 ↗
• MalfunctionSep 4, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 67 IU/ML, REPEAT ON AN ALINITY WAS >100 IU/ML, REPEAT WITH 1:5 DILUTION ON THE ALINITY = 123 IU/ML A RESULT OF 123 IU/ML WAS REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20142207 ↗
• MalfunctionJun 4, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH AND PROVIDED THE FOLLOWING INFORMATION FOR 1 PATIENT: ON (B)(6) 2024 SAMPLE ID (B)(6) INITIAL RESULT WAS 0.4633 UIU/ML AND REPEAT WAS 0.8393 UIU/ML THE CUSTOMER REPORTED A SAMPLE WAS RECOLLECTED WHICH GENERATED RESULT OF 5.6968 UIU/ML. ADDITIONAL PATIENT LABORATORY DATA: FREE T4 WAS 7.2487 PMOL/L AND REPEAT RESULTS WAS 6.8814 AND 7.3813 PMOL/L (PACKAGE INSERT REFERENCE RANGE IS 0.70 NG/DL TO 1.48 NG/DL / 9.0104 TO 19.0506 PMOL/L) UPON FURTHER REVIEW, ANALYZER LOG DATA IDENTIFIED ERROR MESSAGES OF FALSE 3350 UNABLE TO PROCESS TEST, ASPIRATION ERROR FOR (PIPETTER) AT (SH SAMPLE). 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 19463249 ↗
• MalfunctionMay 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH FOR A 72-YEAR-OLD OUTPATIENT CARDIOLOGY DEPARTMENT DUE TO ATRIAL SEPTAL DEFECT. THE PATIENT HAS A MEDICAL HISTORY OF HASHIMOTO¿S DISEASE. THE PATIENT IS CONSULTING ANOTHER MEDICAL INSTITUTION FOR THEIR THYROID DISEASE. THE TSH RESULTS WERE COMPARED BETWEEN OTHER PLATFORMS. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024, SID (B)(6): ARCHITECT TSH = 4.062 / 4.068 UIU/ML (USING LOT 56169UD00) LUMIPULSE TSH = 9 UIU/ML COBAS OUTSOURCING TSH = 10 UIU/ML OTHER TESTING: ARCHITECT BNP = 33.9 PG/ML ARCHITECT FT4 = 0.92 NG/ DL LUMIPULSE FT4 = 0.9 NG/ML COBAS OUTSOURCING FT4 = 0.9 NG/ML ON (B)(6) 2024, SID (B)(6) (SAME SPECIMEN): ARCHITECT TSH = 3.9827 UIU/ML (USING LOT 57370UD00) ARCHITECT FREE T4 = 0.90 NG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333430 ↗
• MalfunctionMay 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH FOR A 72-YEAR-OLD OUTPATIENT CARDIOLOGY DEPARTMENT DUE TO ATRIAL SEPTAL DEFECT. THE PATIENT HAS A MEDICAL HISTORY OF HASHIMOTO¿S DISEASE. THE PATIENT IS CONSULTING ANOTHER MEDICAL INSTITUTION FOR THEIR THYROID DISEASE. THE TSH RESULTS WERE COMPARED BETWEEN OTHER PLATFORMS. THE FOLLOWING DATA WAS PROVIDED: ON 18MAR2024, SID (B)(6). ARCHITECT TSH = 4.062 / 4.068 UIU/ML (USING LOT 56169UD00) LUMIPULSE TSH = 9 UIU/ML COBAS OUTSOURCING TSH = 10 UIU/ML OTHER TESTING: ARCHITECT BNP = 33.9 PG/ML ARCHITECT FT4 = 0.92 NG/ DL LUMIPULSE FT4 = 0.9 NG/ML COBAS OUTSOURCING FT4 = 0.9 NG/ML ON 02MAY2024, SID (B)(6) (SAME SPECIMEN): ARCHITECT TSH = 3.9827 UIU/ML (USING LOT 57370UD00) ARCHITECT FREE T4 = 0.90 NG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333398 ↗
• MalfunctionMay 13, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH AND PROVIDED THE FOLLOWING DATA FOR A 10 YEAR OLD (SAMPLE ID (B)(6)): ON (B)(6) 2024 INITIAL TSH RESULT WAS 0.613 AND REPEAT RESULT ON 30 APR WAS 0.6590 (REFERENCE RANGE 0.700-5.700 UIU/ML). SAMPLE SENT AN OUTSIDE LAB AND ON 27 APR GENERATED A RESULT OF 1.24 (REFERENCE RANGE 0.60-4.84 UIU/ML). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298887 ↗
• MalfunctionJan 9, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS FOR TWO PATIENTS. THE SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED. IT WAS REPORTED THAT ERROR CODE 3000 (LIQUID LEVEL SENSE) AND ERROR CODE 3350 (ASPIRATION ERROR) WERE ALSO GENERATED ON THE ARCHITECT TSH REAGENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6) TSH RESULT = 0.0155 IU/ML; REPEAT RESULT = 0.6473 IU/ML. (B)(6) 2023 SID (B)(6) TSH RESULT = 0.0053 IU/ML; REPEAT RESULT = 0.6473 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480916 ↗
• MalfunctionJan 8, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A 10-YR OLD MALE PATIENT. RESULTS PROVIDED: (B)(6)2023 ARCHITECT SID (B)(6)= 0.146 / 0.2660 UIU/ML, ANOTHER ALINITY = 0.2306 UIU/ML (NORMAL RANGE: 0.700-5.700 UIU/ML) (B)(6)2023 ROCHE = 1.510 UIU/ML (NORMAL RANGE: 0.60-4.84 UIU/ML) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462791 ↗
• MalfunctionDec 18, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULT FOR ONE PATIENT WHEN COMPARED TO ANOTHER PLATFORMS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) ARCHITECT TSH RESULT = 2.393 MIU/L 27NOV2023 ROCHE TSH RESULT = 32.30, FT4 RESULT = 19.6 30NOV2023 TOSOH TSH RESULT = 13.353 UIU/ML PATIENT¿S PREVIOUS RESULTS (ONE YEAR PRIOR): ARCHITECT RESULTS = NORMAL (NO SPECIFIC DATA PROVIDED) ROCHE/BECKMAN/SIEMENS RESULTS: TSH WAS HIGH, FREE T3 AND FREE T4 WERE NORMAL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18349405 ↗
• MalfunctionNov 28, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT THYROID STIMULATING HORMONE (TSH) RESULTS FOR ONE PATIENT. THE TSH RESULT WAS HIGHER ON ANOTHER METHOD. THE FOLLOWING DATA PROVIDED: ARCHITECT RESULT = 14.1. ROCHE COBAS RESULT = 24.5. ARCHITECT TSH REFERENCE RANGE: 0.35 ¿ 4.94 MIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221447 ↗
• MalfunctionNov 28, 2023Low Test Results; Low Test Results

  THE CUSTOMER SUSPECTS THAT FALSELY DECREASED ARCHITECT TSH RESULTS WERE GENERATED FOR A 71 YEAR OLD MALE PATIENT. SID: (B)(6). (B)(6) 2023. ARCHITECT TSH: 3.87 MIU/ML (NORMAL). SAME SAMPLE AFTER RE-CENTRIFUGATION. (B)(6) 2023. ARCHITECT TSH: 4.64 MIU/ML (NORMAL). TSH REFERENCE RANGE: 0.35 ¿ 4.94 MIU/ML. THE PATIENT HAS MEDICAL HISTORY OF DIABETES MELLITUS, STROKE, RENAL FAILURE, OSTEOARTHRITIS, PAPILLARY THYROID CANCER IN 2013, VITAMIN D1 DEFICIENCY. THE PATIENT VISITED A DIFFERENT FACILITY AT A LATER DATE WITH THE FOLLOWING RESULTS: AIA TSH: 10.077 MIU/ML (HIGH), RETEST VALUE: 6.00 MIU/ML (HIGH) THE PATIENT'S HISTORICAL RESULTS ARE AS FOLLOWS: DATE, TSH RESULT (B)(6) 2023, 0.78 MIU/ML. (B)(6) 2023, 1.73 MIU/ML. (B)(6) 2023, 2.83 MIU/ML. (B)(6) 2023, 2.29 MIU/ML. (B)(6) 2023, 4.64 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18218561 ↗
• MalfunctionNov 21, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A MALE PATIENT HAS HIS THYROID CHECKED EVERY 1 TO 2 MONTHS. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED TSH STANDARD VALUE: 0.35-4.94 UIU/ML). (B)(6) 2023 TSH RESULT WAS 3.79 UIU/ML. (B)(6) 2023 REPEATED TSH RESULT OF THE ORIGINAL SAMPLE WAS 6.11 UIU/ML. THE CUSTOMER BELIEVES THE RESULT FROM (B)(6) 2023 IS CORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182574 ↗
• MalfunctionNov 6, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT TSH RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0.35-4.94 MIU/L): ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL RESULT = ASPIRATION ERROR EC 3350, REPEAT = 0.292 MIU/L SAME PATIENT, NEW SAMPLE OBTAINED. SAMPLE ID (B)(6) RESULTS = 3.4883 AND 3.3298 MIU/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073958 ↗