Alinity 07P4820Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00380740131142), received between Aug 20, 2018 and Sep 1, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (38 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543463 ↗
• MalfunctionJun 12, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TSH RESULTS FOR AN ONCOLOGY PATIENT (POST CHEMOTHERAPY). RESULTS WERE NOT CONSISTENT WITH PREVIOUS HISTORY AND WERE QUESTIONED BY THE MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. (B)(6) 2026- RESULTS = >100 MIU/ML, HISTORICAL RESULTS = 0.1MIU/ML. REPEAT RESULTS FROM MULTIPLE SAMPLE TUBES/TWO DIFFERENT PROCESSING MODULE = >100 MIU/ML, >100 MIU/ML ON ONE PROCESSING MODULE AND >100 MIU/ML AND 60 MIU/ML ON ANOTHER PROCESSING MODULE. NO ADDITIONAL PATIENT INFORMATION OR PROCESSING MODULE INFORMATION WAS AVAILABLE. THE CUSTOMER REFERENCE RANGE = 0.35-4.94 MIU/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491225 ↗
• MalfunctionApr 6, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I TSH GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2026 SAMPLE ID 105105 TSH RESULT WAS 0.2512 AND WHEN REPEATED THE RESULT WAS 0.2653 (ALINITY REFERENCE RANGE 0.35-4.94 MIU/ML) TSH RESULT ON THE ROCHE ANALYZER AT ANOTHER HOSPITAL WAS 0.469 MIU/ML. (NORMAL RANGE FOR TSH ASSAY ON THE ROCHE ANALYZER: 0.27-4.2 MIU/ML) WHEN THE SAMPLE WAS RETESTED ON THE SNIBE PLATFORM, THE RESUTLS WERE 0.304 MIU/ML & 0.28 MIU/ML. (SNIBE REFERENCE RANGE: 0.3 - 4.5 MIU/ML) PATIENT INFORMATION: MALE; 46 YEARS OLD. DIAGNOSTICS: A HYPERTENSIVE CRISIS; THE PATIENT IS NOT TAKING ANY MEDICATION. ADDITIONAL LABORATORY DATA PROVIDED: FT4 12.97 PMOL/L; TNI MI RS 2.0 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796180 ↗
• MalfunctionOct 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE ALINITY I TSH RESULTS ON A NEWBORN (DOB (B)(6) 2025) FEMALE PATIENT. THE RESULT PROVIDED WERE: SID (B)(6) INITIAL=5.1951 UIU/ML /REPEATED FROM PRIMARY TUBE=2.8696 UIU/ML. REPEATED AFTER RECENTRIFUGED AND FROM ALIQUOT=4.3479 UIU/ML. REPEATED=5.8104 UIU/ML. LABORATORY REFERENCE RANGE FOR TSH=0.35 TO 4.94 UIU/ML. ADDITIONAL INFORMATION PROVIDED: FT3=2.69 PG/ML; FT4=27.4 PMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393783 ↗
• MalfunctionSep 30, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I TSH RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR THREE PATIENT SAMPLES. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS. THE SAMPLES WERE REPEATED ON A DIFFERENT ANALYZER, WHICH YIELDED HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL REFERENCE RANGE: 0.5 TO 5.0 MIU/L. PATIENT #1: INITIAL RESULT = <0.10 MIU/L, REPEAT RESULT = 3.95 MIU/L. PATIENT #3: INITIAL RESULT = <0.10 MIU/L, REPEAT RESULT = 1.94 MIU/L. PATIENT #5: INITIAL RESULT = <0.10 MIU/L, REPEAT RESULT = 0.90 MIU/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23181026 ↗
• MalfunctionMay 29, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED RESULT FOR ALINITY THYROID STIMULATING HORMONE (TSH) FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT. THE CUSTOMER REPEATED THE PATIENT WITH LOWER RESULTS ON THE ARCHITECT. THE FOLLOWING DATA PROVIDED: ALINITY RESULT = >100 UIU/ML MIU/L REPEAT RESULT = 0.5 UIU/ML 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 22107361 ↗
• MalfunctionJan 3, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I TSH RESULT FOR A MALE PATIENT DIAGNOSED WITH CHRONIC NEPHRITIS AND DIABETES. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 INITIAL RESULT = 0.07 UIU/ML; (B)(46.2024 INITIAL RESULT = 150 UIU/ML. CLINICAL PRESENTATION OF THE PATIENT DOES NOT INDICATE HASHIMOTO¿S DISEASE OR OTHER CONDITION THAT WOULD CAUSE A RISE IN TSH VALUES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066442 ↗
• MalfunctionDec 19, 2024High Test Results; High Test Results

  A LITERATURE ARTICLE BY INGO MROSEWSKI, VIOLA DANNHEIM, ROBERT KLETT, MATTHIAS URBANK, SILVIA STOBBE, JOCHEN R ITTNER AND MARTIN BIDLINGMAIER, ¿RARE COINCIDENCE: MACRO-THYROID-STIMULATING HORMONE AND MULTIPLE MANUFACTURER-SPECIFIC INTERFERENCES IN THYROID HORMONE IMMUNOASSAYS¿ ANNALS OF CLINICAL BIOCHEMISTRY 2024, VOL 61(6) 484-489, DOCUMENTED FALSELY ELEVATED ALINITY I TSH RESULTS FOR A 44-YEAR-OLD MALE PATIENT WITH NO SIGNS OF THYROID DISEASE AND NO PERSONAL OR FAMILY HISTORY OF THYROID DYSFUNCTION. THE FOLLOWING DATA WAS PROVIDED: INITIAL WORK-UP IN JANUARY 2023 GENERATED BY NON-ABBOTT DEVICE: ROCHE E801 TSH RESULT = 63.9 MIU/L (REFERENCE RANGE: 0.40 TO 4.00 MIU/L), SIEMENS ADVIA CENTAUR XPT TSH RESULT = 8.89 MIU/L (REFERENCE RANGE: 0.35 TO 5.50 MIU/L, SIEMENS DIMENSION EXL TSH RESULT = 53.2 MIU/L (REFERENCE RANGE: 0.36 TO 3.74 MIU/L), SIEMENS IMMULITE 2000 TSH RESULT = 57.1 MIU/L (REFERENCE RANGE: 0.40 TO 4.00 MIU/L), BECKMAN COULTER/BRAHMS TSH RESULT = 10.3 MIU/L (REFERENCE RANGE: 0.45 TO 4.50 MIU/L). WORK-UP 8 WEEKS LATER: ALINITY I TSH RESULT = 35.4 MIU/L (REFERENCE RANGE: 0.35 TO 4.94 MIU/L), ALINITY I TSH RESULT AFTER HBT (HETEROPHILE BLOCKING TUBE) = 35.8 MIU/L, ALINITY I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20978930 ↗
• MalfunctionOct 25, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I TSH RESULT FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID: (B)(6) INITIAL RESULT = 0.1987 UIU/ML, REPEAT RESULT ON (B)(6) 2024 WITH RESULT = 1.0041 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533087 ↗
• MalfunctionOct 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT ALINITY I TSH RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 35-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 ALINITY I TSH RESULT = 0.131 IU/ML (REFERENCE RANGE: 0.4 TO 4.3 IU/ML). ON (B)(6) 2024, THE PATIENT WAS PREVIOUSLY TESTED AT ANOTHER LAB (DIAGNOLAB) WHICH UTILIZED THE ARCHITECT I1000SR PROCESSING MODULE AND THE FOLLOWING TSH RESULT WAS OBTAINED: REFERENCE RANGE: 0.350 TO 4.940 IU/ML. (B)(6)2024 SID (B)(6) ARCHITECT TSH RESULTS = 0.72, 0.70 IU/ML. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447557 ↗
• MalfunctionSep 30, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.32 TO 5 MUI/L): ON (B)(6)2024, SID (B)(6), INITIAL TSH RESULT= 2.63 MUI/L; UNABLE TO REPEAT DUE TO LOW SAMPLE VOLUME. HISTORICAL TSH RESULT (2023) = 5.018 MIU/L. OTHER SAMPLES COLLECTED FOR COMPARISON: ON (B)(6) 2024, SID (B)(6), INITIAL RESULT= 87.35 MUI/L. ON (B)(6) 2024, SID (B)(6), INITIAL RESULT= 94.7 MUI/L. ON (B)(6) 2024, SID (B)(6), INITIAL RESULT= 62.17 MUI/L. ON (B)(6)2024, SID (B)(6), INITIAL RESULT= 61.65 MUI/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332768 ↗
• MalfunctionSep 23, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH RESULTS FOR A PATIENT THAT HAS A DIAGNOSIS OF GRAVES¿ DISEASE, TRAB POSITIVE, AND IS TAKING MERCAZOLE 5MG DAILY. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) TSH RESULT = <0.0083 IU/ML, REPEAT RESULT = 0.0086 IU/ML. PATIENT¿S PREVIOUS TSH RESULTS: (B)(6) TSH 0.065 IU/ML, (B)(6) TSH 0.416 IU/ML, (B)(6) TSH 3.189 IU/ML. ADDITIONAL LAB DATA PROVIDED: FREE T4 RESULT = 1.41 NG/ML ¿ RESULT WAS NORMAL FREE T3 RESULT IS ELEVATED, HOWEVER, NO SPECIFIC DATA PROVIDED NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278891 ↗
• MalfunctionApr 24, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I TSH RESULTS FOR MULTIPLE PATIENTS THAT WERE REPORTED OUT OF THE LAB. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE = 0.7 ¿ 4.17 UIU/ML): ON (B)(6) 2024, SID (B)(6), INITIAL RESULT=0.01 UIU/ML; ON (B)(6) 2024 REPEATED RESULT= 1.61 UIU/ML. ON (B)(6) 2024 ,SID (B)(6), INITIAL RESULT=0.01 UIU/ML; ON (B)(6) 2024 REPEATED RESULT=1.61 UIU/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177462 ↗
• MalfunctionMar 25, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS FOR ALINITY THYROID STIMULATING HORMONE (TSH) FOR ONE PATIENT. THE RESULTS WERE NOT REPORTED OUT. THE CUSTOMER REPEATED THE PATIENT WITH HIGHER RESULTS ON THE ARCHITECT. THE FOLLOWING DATA PROVIDED: SID (B)(6) ALINITY RESULT = 0.21 MIU/L PROCESSED ON 13MAR2024 NORMAL RANGE = 0.4-4.0 MIU/L ARCHITECT RESULT = 11 MIU/L PROCESSED ON (B)(6) 2024 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968934 ↗
• MalfunctionMar 19, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH RESULTS FOR A 10-YEAR-OLD PATIENT. ON (B)(6)2024, SID (B)(6) INITIAL RESULT WAS 0.26 UIU/ML (NORMAL RANGE IS 0.64-6.27 UIU/ML), THE DOCTOR QUESTIONED THE RESULT. TESTING WAS REPEATED OUT OF THE PRIMARY TUBE AND THE RESULT WAS 1.30 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934698 ↗
• MalfunctionFeb 22, 2024High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULTS AND A FALSELY DEPRESSED ALINITY I TSH RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL FREE T4 RESULT = 1.69 NG/DL, REPEAT = 1.26 NG/DL. INITIAL TSH RESULT = 4.31 UIU/ML, REPEAT = 9.62 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18756960 ↗
• MalfunctionJan 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TSH RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 49 YEAR OLD FEMALE PATIENT UNDERGOING DIALYSIS. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023 SAMPLE ID (B)(6) TSH RESULT = 0.0670 UIU/ML ON (B)(6) 2023 SAME PATIENT, NEW SAMPLE OBTAINED. SAMPLE ID (B)(6) TSH RESULT = 0.0673 UIU/ML SAMPLE ID (B)(6) (SAME PATIENT AS SID (B)(6) TSH RESULT = 0.0647 UIU/ML REPEAT MEASUREMENT ON (B)(6) (SAME PATIENT AS SID (B)(6) SAMPLE ID (B)(6) TSH RESULT = 0.0195 UIU/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521379 ↗
• MalfunctionDec 7, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TSH RESULTS WHICH QUESTIONED BY THE PHYSICIAN ON ONE 12MONTH OLD PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6)2023 SID (B)(6) INITIAL= 0.0875 MIU/ML /REPEATED FROM /EDTA SAMPLE =0.0820 MIU/ML /AT REFERENCE LABORATORY=0.0766 AND 0.0878 MIU/ML. ON (B)(6)2023 REDRAWN AND REPEATED PER PHYSICIAN REQUEST SID (B)(6)= 0.8318 MIU/ML /SAME RESULTS AT REFERENCE LABORATORY LABORATORY REFERENCE RANGE FOR TSH= 0.35 TO 4.94 MIU/ML ADDITIONAL INFORMATION PROVIDED: FT3=0.79 NG/ML (REFERENCE RANGE=0.35 TO 1.93 NG/ML); FT4=10.42 PMOL/L (REFERENCE RANGE=9 TO 19 PMOL/L) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18284171 ↗
• MalfunctionNov 27, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I TSH RESULT GENERATED ON AN ALINITY I PROCESSING MODULE. SID (B)(6) INITIAL RESULT GENERATED ON COBAS SYSTEM = 9.77 UIU/ML, REPEAT RESULT ON COBAS = 9.82 UIU/ML, WHICH WERE BOTH HIGH. THE CUSTOMER RECHECKED THE SAMPLE ON THE ALINITY I GENERATING A RESULT = 0.028 UIU/ML (LOW) AND 9.26 UIU/ML (HIGH). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212518 ↗
• MalfunctionSep 14, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY THYROID STIMULATING HORMONE (TSH) RESULTS FOR ONE NEONATAL PATIENT. THE RESULTS WERE NOT REPORTED OUT AS THEY DID NOT MATCH THE PATIENT¿S CLINICAL PICTURE. THE SAMPLE WAS VERY HEMOLYZED AND HAD PARTICLES IN IT. ANOTHER SAMPLE WAS TESTED AND GAVE THE EXPECTED RESULTS. THE FOLLOWING DATA PROVIDED: INITIAL SAMPLE TESTED ON 02SEPT2023 SID (B)(6) TSH RESULT = 0.4042 UIU/ML SECOND SAMPLE TESTED ON 06SEPT2023 SID (B)(6) TSH RESULT = 5.15 UIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745985 ↗
• MalfunctionSep 5, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I TSH RESULT FOR A NEWBORN TWIN SAMPLE. (CUSTOMER PROVIDED NORMAL RANGE USED: TSH: 0.35 - 4.94 UUI/ML) 25AUG2023 TWIN#2 SID (B)(6) FIRST DRAW WAS POOR/LOW VOLUME AND INITIALLY PRODUCED AN ASPIRATION ERROR MESSAGE 3424-D026 (ASPIRATION ERROR IN SAMPLE TUBE), THE SAMPLE WAS RETESTED WITH A TSH RESULT OF 0.16 UUI/ML A SECOND SAMPLE FOR SAME PATIENT WITH SID (B)(6) TSH WAS >100 UUI/ML (CORRECT RESULT) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682501 ↗
• MalfunctionMay 30, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TSH RESULTS FOR ONE PATIENT. ADDITIONALLY, AN INSTRUMENT ERROR MESSAGE WAS NOTED ¿ORDER CANNOT BE CREATED. HIL MULTIPLE MEASUREMENTS OR CALCULATION ITEM (TSH-IFCC) ALREADY EXIST¿. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) TSH-IFCC RESULT 0.2352 UIU/ML, REPEATED TSH 0.2158 AND 0.4407 UIU/ML. THE CUSTOMER BELIEVES THAT 0.4407 UIU/ML IS THE CORRECT RESULT. THE PATIENT HAD PREVIOUSLY TESTED AT AROUND 1.30 / 1.16 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020718 ↗
• MalfunctionMar 22, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I TSH RESULTS FOR ONE PATIENT SAMPLE. THE FOLLOWING RESULTS WERE: INITIAL TSH RESULT = 3 UIU/ML; REPEAT RESULTS = 6 AND 6 UIU/ML (REFERENCE RANGE: 0.35-4.94 UIU/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594839 ↗
• MalfunctionJan 30, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TSH RESULT FOR ONE PATIENT WHEN COMPARED TO THE RESULT FROM THE MAIN HOSPITAL. THE SAMPLE WAS REPEATED, AND THE RESULT WAS WITHIN NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: NORMAL REFERENCE RANGE IS 0.35 TO 4.94 UIU/ML. ON (B)(6) 2023, SID: (B)(6), INITIAL RESULT (PLASMA SAMPLE) = < 0.0083 UIU/ML. ON (B)(6) 2023, (MAIN HOSPITAL; DIFFERENT DRAW) RESULT = 2.369 UIU/ML. ON (B)(6) 2023, SID: (B)(6), RECENTRIFUGED AND REPEATED RESULT = 1.3 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263296 ↗
• MalfunctionJan 24, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED RESULT FOR ALINITY I TSH AND PROVIDED THE FOLLOWING DATA (CUSTOMER NORMAL RANGE IS 0.45-4.50 UIU/ML): ON (B)(6) 2023 SAMPLE ID (B)(6) HAD AN INITIAL RESULT OF 0.19 AND THE CUSTOMER REPORTED THAT THIS SAMPLE WAS SLIGHTLY HEMOLYZED. THE PATIENT WAS REDRAWN ON (B)(6) 2023, SAMPLE ID (B)(6), WHICH HAD AN INITIAL RESULT OF 7.02. BOTH SAMPLES WERE REPEATED ON (B)(6) 2023 AND GENERATED THE FOLLOWING RESULTS: SID (B)(6)WAS 6.04 AND SAMPLE ID (B)(6) WAS 7.10. IT WAS REPORTED THAT THE CUSTOMER CORRECTED THE INITIAL RESULTS OF 0.19 AND CONFIRMED THAT THE PATIENT DID NOT RECEIVE ANY TREATMENT BASED UPON THE INITIAL RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16238317 ↗