ARCHITECT 7K62-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00380740014247), received between Aug 22, 2016 and Sep 15, 2025 — classified as 4 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (56 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.350-4.940 MUI/L): (B)(6) 2025, SID (B)(6), INITIAL TSH RESULT= 0.0569 MUI/L; (B)(6) 2025, HISTORICAL RESULT= 0.0483 MUI/L; REPEAT RESULT (ROCHE)= 0.77 MUI/L (REFERENCE RANGE 0.27-4.20 MUI/L); (B)(6) 2025, HISTORICAL RESULT (ROCHE)= 0.88 MUI/L; REPEAT RESULT (SIEMENS)= 0.70 MUI/L (REFERENCE RANGE 0.55-4.78 MUI/L) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051856 ↗
• MalfunctionApr 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR A 17-YEAR-OLD MALE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: ARCHITECT RESULTS (B)(6) 2025, SID (B)(6): TSH: 0.09 UIU/ML, CUSTOMER PROVIDED NORMAL VALUE: 0.35 TO 4.94 UIU/ML, (0.09 MIU/L, NORMAL VALUE: 0.35 TO 4.94 MIU/L). BECKMAN RESULTS AT ANOTHER LABORATORY: TSH: 1.49 MIU/L (CUSTOMER PROVIDED NORMAL VALUE: 0.38 TO 5.33 MIU/L). THE PHYSICIAN QUESTIONED THE RESULT GENERATED ON THE ARCHITECT AS THEY DID NOT MATCH CLINICAL PRESENTATION INCLUDING NO KNOWN PATHOLOGY, NO TSH ANTI-RECEPTOR ANTIBODIES, AND A NORMAL THYROID ULTRASOUND. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21786205 ↗
• MalfunctionMar 14, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT TSH RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT, WHICH WAS INCONSISTENT WITH RESULTS FROM OTHER PLATFORMS. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 0.35 TO 5.50 IU/ML. SID (B)(6): (B)(6) 2025 ARCHITECT TSH RESULT = 5.460 IU/ML, AUTOBIO PLATFORM RESULT = 8.425 IU/ML, OUTSOURCED RESULT = 9.10 IU/ML, THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604258 ↗
• MalfunctionOct 8, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR ONE PATIENT. ON (B)(6) 2024, SID (B)(6) WAS A SHORT SAMPLE AND INITIALLY GAVE A SAMPLING ERROR (ON ALINITY (B)(6)), THEN THE SAMPLE WAS RUN ON ANOTHER INSTRUMENT (ON ARCHITECT ISR51888) AND THE RESULT WAS 0.0315 MIU/L. ON (B)(6) 2024, ANOTHER SAMPLE WITH MORE VOLUME FROM THE SAME PATIENT (SID (B)(6)) WAS TESTED AND THE RESULT WAS 4.64 MIU/L, WHICH IS CONSISTENT WITH PATIENTS PREVIOUS AND RESULTS. REFERENCE INTERVAL FOR TSH 0.40 - 4.00 MIU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20400059 ↗
• MalfunctionMay 31, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT TSH RESULT FOR A 34-YEAR-OLD MALE PATIENT WHO WAS DIAGNOSED WITH GRAVES DISEASE 4 YEARS AGO. AT THE TIME OF DIAGNOSIS, THE PATIENT WAS PRESCRIBED PROPYCIL. HIS FREE T3 AND FREE T4 LEVELS HAVE REMAINED STABLE BUT HIS TSH LEVELS HAVE REMAINED LOW. IN (B)(6) 2024, THE PATIENT WENT TO ANOTHER HOSPITAL AND HIS TSH LEVELS WERE NORMAL WITH AN UNKNOWN METHOD. THE PATIENT DISCONTINUED THE PROPYCIL. ON (B)(6) 2024, THE ORIGINAL LABORATORY HAD THE PATIENT REDRAWN (GEL BARRIER TUBE, HEPARIN TUBE, EDTA TUBE) TO PERFORM ADDITIONAL TESTING. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGES: ABBOTT IS 0.3 TO 4.2 UIU/ML, ROCHE COBAS IS 0.3 TO 4.0 UIU/ML)): GEL BARRIER TUBE: ARCHITECT I2000 = 0.1517 UIU/ML, ARCHITECT I1000 = 0.1488 UIU/ML, ARCHITECT AT MEDICANA HAZNEDAR = 0.1754 UIU/ML, ALINITY AT MEMORIAL BAHCELIEVLER = 0.1615 UIU/ML, ARCHITECT AT MEDICAL PARK BAHCELIEVLER = 0.160 UIU/ML, ARCHITECT AT FLORYA = 0.1548 UIU/ML, ARCHITECT AT SYNLAB = 0.18 UIU/ML, ROCHE COBAS AT DUZEN = 1.05 UIU/ML. HEPARIN TUBE: ARCHITECT I2000 = 0.1516 UIU/ML, ARCHITECT I1000 = 0.139 UIU/ML. EDTA TUBE: ARCHITECT I2000 = 0.1477 UIU/ML, ARCHITECT I100

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19434032 ↗
• MalfunctionMay 21, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH AND PROVIDED THE FOLLOWING DATA: THE CUSTOMER'S REFERENCE RANGE IS: REFERENCE RANGE: KIDS 4 DAYS - 5 MONTHS 0.73 - 4.8 MIU/L, 6 MONTH - 13 YEARS 0.70 - 4.2 MIU/L, 14 - 18 Y 0.50 - 3.4 MIU/L, ADULTS OVER 18 Y 0.50 - 3.6 MIU/L. ON (B)(6) 2024 SAMPLE ID (B)(6) TSH RESULT WAS 0.38 MIU/L. A NEW SAMPLE FROM THE SAME PATIENT (SAMPLE ID (B)(6)) WAS OBTAINED AND TESTED ON (B)(6) 2024, WHICH GENERATED A RESULT OF 2.98 MIU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19365455 ↗
• MalfunctionApr 3, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024, INITIAL TSH RESULT = 11 UIU/ML; REPEAT RESULT ON (B)(6) 2024 = 10.182 UIU/ML. ON (B)(6) 2024, TSH RESULT FROM A NEW SAMPLE = 1.74 UIU/ML; REPEAT RESULT ON (B)(6) 2024 = 1.561 UIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038183 ↗
• MalfunctionNov 17, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2023 SID (B)(6) /REPEATED ON (B)(6) 2023=(B)(6) LABORATORY REFERENCE RANGE FOR TSH=0.35 TO 4.94 UIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161787 ↗
• MalfunctionJul 25, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT TSH RESULT FOR ONE PATIENT DIAGNOSED WITH AUTOIMMUNE THYROIDITIS. THE FOLLOWING DATA WAS PROVIDED: 13JUN2023 INITIAL RESULT = 17.06 MIU/L (TESTING COMPLETED AT ANOTHER LABORATORY). 19JUN2023 SID (B)(6) INITIAL RESULT = 6.98 MIU/L. 29JUN2023 INITIAL RESULT = 17.7 MIU/L (TESTING COMPLETED AT ANOTHER LABORATORY). 01JUL2023 INITIAL RESULT = 14.05 MIU/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388550 ↗
• InjuryJun 7, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A PRETERM NEWBORN PATIENT. RESULTS PROVIDED: 08MAR2023 SID (B)(6) ON LOT# (47474UD00) = 7.016, 1:10 DILUTION = 14.5 UIU/ML, COBAS = 18.62 (NO UOM PROVIDED). NEW SAMPLE, SAME PATIENT 13MAR2023 SID (B)(6) (LOT# 48544UD00) = 4.58, 1:10 DILUTION = 15.092 / 11.934 UIU/ML, COBAS = 18.2 (NO UOM PROVIDED). THE NEONATAL PRETERM INFANT WITH DOWN SYNDROME HAD A DELAY IN THYROID TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084244 ↗
• MalfunctionMay 30, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS WHEN COMPARED TO RESULTS FROM ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). INITIAL RESULT TSH 4.53 IU/L, RETESTED ON ANOTHER INSTRUMENT (SN ISR54829) RESULT TSH 10.64 IU/L. RETESTED ON ROCHE COBAS RESULT TSH 16.6 IU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020796 ↗
• InjuryApr 4, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) SID (B)(6) (LOT# 48544UD00) = 4.58, 1:10 DILUTION = 15.092 / 11.934 UIU/ML, COBAS = 18.2 NO UOM PROVIDED. NORMAL RANGE: (0.35-4.95 UIU/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674478 ↗
• InjuryDec 22, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR MULTIPLE PEDIATRIC SAMPLES. THE FOLLOWING EXAMPLE DATA WAS PROVIDED (NORMAL RANGE - 0.35 IU/ML TO 4.94 IU/ML): (B)(6) 2022 SAMPLE ID (B)(6) INITIAL RESULT = 0.57 UIU/ML, REPEAT RESULT IN 1:10 DILUTION = 0.659 UIU/ML. (B)(6) 2022 SAMPLE ID (B)(6) INITIAL RESULT = 0.11 UIU/ML, REPEAT = 1.34 UIU/ML, REPEAT RESULT IN 1:15 DILUTION = 1.62 UIU/ML. (B)(6) 2022 SAMPLE ID (B)(6) INITIAL RESULT = 1.51 UIU/ML, REPEAT RESULT IN 1:5 DILUTION = 2.14 UIU/ML (B)(6) 2022 SAMPLE ID (B)(6) INITIAL RESULT = 0.04 UIU/ML, REPEAT RESULT AT A DIFFERENT LABORATORY = 2.0 UIU/ML. (B)(6) 2022 SAMPLE ID (B)(6) INITIAL RESULT = 0.7 UIU/ML, REPEAT = 3.07 UIU/ML, REPEAT RESULT IN 1:6 DILUTION = 2.4534 UIU/ML. THE CUSTOMER FURTHER INDICATED THE PRECISION ISSUE ASSOCIATED WITH THE PEDIATRIC SAMPLES HAVE THE POTENTIAL FOR FAR-REACHING CONSEQUENCES, E.G. UNNECESSARY CONTROL VISITS FOR NEWBORNS IN THE HOSPITAL, UP TO ACTUALLY UNNECESSARY DRUG TREATMENT. TO DATE IT IS UNKNOWN IF THERE WAS ANY UNNECESSARY TREATMENT GIVEN OR ANY ADVERSE IMPACT TO ANY PATIENTS.

  Patient problems: Insufficient Information

  MAUDE report 16035636 ↗
• InjuryDec 22, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR MULTIPLE PEDIATRIC SAMPLES. THE FOLLOWING EXAMPLE DATA WAS PROVIDED (NORMAL RANGE - 0.35 IU/ML TO 4.94 IU/ML): ON (B)(6) 2022, SAMPLE (B)(6). INITIAL RESULT = 0.57 UIU/ML, REPEAT RESULT IN 1:10 DILUTION = 0.659 UIU/ML (B)(6) 2022. SAMPLE (B)(6). INITIAL RESULT = 0.11 UIU/ML, REPEAT = 1.34 UIU/ML, REPEAT RESULT IN 1:15 DILUTION = 1.62 UIU/ML (B)(6) 2022. SAMPLE (B)(6). INITIAL RESULT = 1.51 UIU/ML, REPEAT RESULT IN 1:5 DILUTION = 2.14 UIU/ML (B)(6) 2022. SAMPLE (B)(6). INITIAL RESULT = 0.04 UIU/ML, REPEAT RESULT AT A DIFFERENT LABORATORY = 2.0 UIU/ML ON B)(6) 2022, SAMPLE (B)(6). INITIAL RESULT = 0.7 UIU/ML, REPEAT = 3.07 UIU/ML, REPEAT RESULT IN 1:6 DILUTION = 2.4534 UIU/ML. THE CUSTOMER FURTHER INDICATED THE PRECISION ISSUE ASSOCIATED WITH THE PEDIATRIC SAMPLES HAVE THE POTENTIAL FOR FAR-REACHING CONSEQUENCES, E.G. UNNECESSARY CONTROL VISITS FOR NEWBORNS IN THE HOSPITAL, UP TO ACTUALLY UNNECESSARY DRUG TREATMENT. TO DATE IT IS UNKNOWN IF THERE WAS ANY UNNECESSARY TREATMENT GIVEN OR ANY ADVERSE IMPACT TO ANY PATIENTS.

  Patient problems: Insufficient Information

  MAUDE report 16035635 ↗
• MalfunctionDec 7, 2022Low Test Results; Low Test Results

  THE CUSTOMER HAS OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS WITH PATIENTS WITH A DISORDER WITH CLOTTING CALLED CONGENITAL DYSFIBRINOGENEMIA/ INHERITED DYSFIBRINOGENEMIA. LITHIUM HEPARIN TUBES HAVE GIVEN NORMAL TEST RESULTS. THE CUSTOMER IS AWARE OF PACKAGE INSERT INSTRUCTIONS, ¿ENSURE THAT COMPLETE CLOT FORMATION IN SERUM SPECIMENS HAS TAKEN PLACE PRIOR TO CENTRIFUGATION. SOME SPECIMENS, ESPECIALLY THOSE FROM PATIENTS RECEIVING ANTICOAGULANT OR THROMBOLYTIC THERAPY MAY EXHIBIT INCREASED CLOTTING TIME. IF SPECIMENS ARE CENTRIFUGED BEFORE A COMPLETE CLOT FORMS, THE PRESENCE OF FIBRIN OR PARTICULATE MATTER MAY CAUSE ERRONEOUS RESULTS.¿ THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 SERUM TSH = 10.7 REPEATED 0.59. PATIENT 1 PLASMA TSH = 10.15 NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936269 ↗
• MalfunctionOct 6, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 (B)(6), INITIAL=3.264 UIU/ML /REPEATED ON ARCHITECT ISR61117=3.005 UIU/ML /ON ROCHE=21.70 UIU/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552624 ↗
• MalfunctionMay 6, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2022, SID (B)(6), INITIAL=0.0072 UIU/ML /REPEATED=3.6095 UIU/ML LABORATORY REFERENCE RANGE FOR TSH=0.35 TO 4.94 UIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14304944 ↗
• MalfunctionMar 25, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH RESULTS FOR ONE PATIENT. THE INITIAL RESULT WAS 2.7894 UUI/ML, REPEATED CLIA METHOD 5.667 / 5.110 UIU/ML (NORMAL RANGE 0.4 TO 4.2 UIU/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13907793 ↗
• MalfunctionNov 29, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT TSH RESULT FOR A PATIENT WHILE RUNNING ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): ON (B)(6) 2021: INITIAL RESULT = 0.050 MIU/L; ON (B)(6) 2021: REPEAT RESULT = 3.039 MIU/L (NORMAL RANGE: 0.35-4.94 MIU/ML) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882775 ↗
• MalfunctionNov 23, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TSH RESULTS ON TWO PATIENTS. RESULTS PROVIDED: (B)(6) 2021 SID (B)(6)= 0.04 UIU/ML (HEPARINIZED SAMPLE), DIFFERENT SAMPLE FROM (B)(6) 2021 UNDER SID (B)(6)= 0.975 UIU/ML, NEW SAMPLE ON (B)(6) 2021 SID (B)(6)= 0.99 UIU/ML; (B)(6) 2021 SID (B)(6)= 0.016 / 0.273 / 0.26 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862324 ↗
• MalfunctionSep 16, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A PATIENT. RESULTS PROVIDED: 09SEP2021 SID (B)(6)= 0.0055 MIU/L, REPEATED ON ANOTHER ARCHITECT = 0.9 MIU/ML. OTHER RESULTS ALSO PROVIDED: FT4 = 61.77 PMOL/L, ANOTHER ARCHITECT = 12.5 / 12.2 PMOL/L LH = 5.22 / 11.96 IU/L FSH = 6.26 / 4.37 IU/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480454 ↗
• MalfunctionJun 28, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS FOR A PATIENT WHEN USING THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED BY THE CUSTOMER DURING PATIENT FOLLOW-UP VISITS BETWEEN (B)(6) TO (B)(6) 2021: ON (B)(6) 2021 SID (B)(6) = TSH (REAGENT LOT 22171UI00 / ARCHITECT (B)(4)) = 0.06 MIU/L, FT3 = 3.40 NG/L, FT4 =7.1 NG/L ON (B)(6) 2021 SID (B)(6) = TSH (REAGENT LOT 23136UI00) = 0.08 MIU /L (RAN ON ALINITY ANALYZER (B)(4)) ON (B)(6) 2021 (NO SAMPLE ID PROVIDED) = TSH 0.05 MIU /L, FT3 = 3.09 NG /L, FT4 = 7.3 NG /L ON (B)(6) 2021 SID (B)(6) = TSH (REAGENT LOT 26154UD00 / ARCHITECT (B)(4)) = 0.06 MIU /L, FT3 = 3.00 NG /L, FT4 = 8.7 NG /L THE PATIENT WAS AT (B)(6) FOR A ROUTINE CHECK-UP AND GENERATED A NORMAL TSH RESULT. THE CUSTOMER WAS ASKED TO SEND THEIR SAMPLE FROM (B)(6) 2021 TO BE RETESTED ON THE ROCHE COBAS. THE FOLLOWING RESULTS WERE TSH = 2.6 MIU/L, FT3 = 3.55 NG/L, AND FT4 = 0.9 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076957 ↗
• MalfunctionJun 28, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TSH RESULTS FOR A PATIENT WHEN USING THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED BY THE CUSTOMER DURING PATIENT FOLLOW-UP VISITS BETWEEN (B)(6) TO (B)(6) 2021: ON (B)(6) 2021 SID (B)(6) = TSH (REAGENT LOT 22171UI00 / ARCHITECT (B)(4)) = 0.06 MIU/L, FT3 = 3.40 NG/L, FT4 =7.1 NG/L ON (B)(6) 2021 SID (B)(6) = TSH (REAGENT LOT 23136UI00) = 0.08 MIU /L (RAN ON ALINITY ANALYZER (B)(4)) ON (B)(6) 2021 (NO SAMPLE ID PROVIDED) = TSH 0.05 MIU /L, FT3 = 3.09 NG /L, FT4 = 7.3 NG /L ON (B)(6) 2021 SID (B)(6) = TSH (REAGENT LOT 26154UD00 / ARCHITECT (B)(4)) = 0.06 MIU /L, FT3 = 3.00 NG /L, FT4 = 8.7 NG /L. THE PATIENT WAS AT (B)(6) FOR A ROUTINE CHECK-UP AND GENERATED A NORMAL TSH RESULT. THE CUSTOMER WAS ASKED TO SEND THEIR SAMPLE FROM (B)(6) 2021 TO BE RETESTED ON THE ROCHE COBAS. THE FOLLOWING RESULTS WERE TSH = 2.6 MIU/L, FT3 = 3.55 NG/L, AND FT4 = 0.9 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076888 ↗
• MalfunctionDec 18, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TSH RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020, SID: (B)(6); INITIAL = 0.0145MIU/ML / RETEST = 2.5 / 2.5 RESULT CONFIRMED ON SAME PATIENT WITH A DIFFERENT TUBE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11036804 ↗
• MalfunctionAug 25, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED DECREASED ARCHITECT THYROID STIMULATING HORMONE (TSH) ASSAY RESULTS FOR AN (B)(6) FEMALE PATIENT. THE CUSTOMER PROVIDED SID (B)(6): INITIAL = 0.085 MIU/L, REPEAT = 0.247 MIU/L (0.5 TO 3.0 MIU/L). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10449880 ↗