Alinity 07P6620Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380740121570), received between Mar 29, 2021 and Sep 14, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “High Test Results” (29 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763360 ↗
• MalfunctionAug 26, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458780 ↗
• MalfunctionJul 29, 2026Imprecise or Erratic Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070262 ↗
• MalfunctionJul 29, 2026Imprecise or Erratic Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070203 ↗
• MalfunctionMay 22, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I PROLACTIN FOR A 52-YEAR-OLD FEMALE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 108.8 TO 557.1 MIU/L): ON (B)(6) 2026, SID (B)(6), INITIAL PROLACTIN RESULT (LOT 84437UD00, ANALYZER (B)(6)= 1398.20 MIU/L; REPEAT RESULT= 1,379.36 MIU/L; (B)(6) 2026, SID (B)(6), PROLACTIN RESULT (LOT 85609UD00, ANALYZER (B)(6)= 1,225.33 MIU/L; REPEAT USING BECKMAN PLATFORM= 298 MIU/L (REFERENCE RANGE 83 TO 504 MIU/L); REPEAT USING ROCHE PLATFORM= 492 MIU/L (REFERENCE RANGE 102 TO 496 MIU/L). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256106 ↗
• MalfunctionMay 22, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I PROLACTIN FOR A 52-YEAR-OLD FEMALE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 108.8 TO 557.1 MIU/L): (B)(6) 2026, SID (B)(6), INITIAL PROLACTIN RESULT (LOT 84437UD00, ANALYZER (B)(6)= 1398.20 MIU/L; REPEAT RESULT= 1,379.36 MIU/L; (B)(6) 2026, SID (B)(6), PROLACTIN RESULT (LOT 85609UD00, ANALYZER (B)(6)= 1,225.33 MIU/L; REPEAT USING BECKMAN PLATFORM= 298 MIU/L (REFERENCE RANGE 83 TO 504 MIU/L); REPEAT USING ROCHE PLATFORM= 492 MIU/L (REFERENCE RANGE 102 TO 496 MIU/L) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256099 ↗
• MalfunctionMar 9, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR A 62-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT (LOT: 72165UD00, (B)(6) = 1980.092 NG/ML, REPEAT WITH 1:10 DILUTION (B)(6) = 3083.830 NG/ML, REPEAT WITH NO DILUTION (B)(6) = 3230.905 NG/ML. ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT (LOT: 75050UD00, (B)(6) = 2225.910 NG/ML, REPEAT (B)(6) = 3468.409 NG/ML, REPEAT WITH 1:10 DILUTION (B)(6) = 3229.661 NG/ML. ON (B)(6) 2026, SID: (B)(6): INITIAL RESULT = 3092.7 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547904 ↗
• MalfunctionMar 9, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR A 62-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6): INITIAL RESULT (LOT 72165UD00, (B)(6) = 1980.092 NG/ML, REPEAT WITH 1:10 DILUTION (B)(6) = 3083.830 NG/ML, REPEAT WITH NO DILUTION (B)(6) = 3230.905 NG/ML. (B)(6) 2025, SID (B)(6): INITIAL RESULT (LOT 75050UD00, (B)(6) = 2225.910 NG/ML, REPEAT (B)(6) = 3468.409 NG/ML, REPEAT WITH 1:10 DILUTION (B)(6) = 3229.661 NG/ML. (B)(6) 2026, SID (B)(6): INITIAL RESULT = 3092.7 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547899 ↗
• MalfunctionMar 9, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR A 62-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6): INITIAL RESULT (LOT 72165UD00, (B)(6) = 1980.092 NG/ML, REPEAT WITH 1:10 DILUTION (B)(6) = 3083.830 NG/ML, REPEAT WITH NO DILUTION (B)(6) = 3230.905 NG/ML. (B)(6) 2025, SID (B)(6): INITIAL RESULT (LOT 75050UD00, (B)(6) = 2225.910 NG/ML, REPEAT (B)(6) = 3468.409 NG/ML, REPEAT WITH 1:10 DILUTION (B)(6) = 3229.661 NG/ML. (B)(6) 2026, SID (B)(6): INITIAL RESULT = 3092.7 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547898 ↗
• MalfunctionFeb 5, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULT A 53YRS OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2026, SID (B)(6), INITIAL= 3168.86 MIU/L (REFERENCE RANGE= 108.78 TO 557.13 MIU/L THE SPECIMEN IS SENT TO ANOTHER LABORATORY FOR POLYETHYLENE GLYCOL (PEG) PRECIPITATION. ON ROCHE ECLIA=536 UUI/ML (REFERENCE RANGE= 127 TO 637 UUI/ML), NO POLYETHYLENE GLYCOL (PEG) PRECIPITATION METHOD PERFORMED DUE TO NORMAL RESULTS ON ROCHE PLATFORM. SAME SPECIMEN REPEATED ON ALINITY ON (B)(6) 2026= 3232.61 MIU/L, 2968.92 MIU/L, 3299.16 MIU/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269209 ↗
• MalfunctionNov 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I PROLACTIN RESULT ON A PATIENT. RESULTS PROVIDED: ON (B)(6) 2025, SID (B)(6) (62-YR OLD MALE) = >27.09, HISTORY OF PROLACTIN OF 5.80 NG/ML; ANOTHER LABORATORY CHEMILUMINESCENCE PLATFORM = 9.6 NG/ML, NORMAL RANGE MALE: 3.46-19.40 NG/ML, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579746 ↗
• MalfunctionNov 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I PROLACTIN RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2025: SID (B)(6) (41-YR OLD FEMALE) = 27.0 NG/ML, DXI RESULT = 20.89 NG/ML, NORMAL RANGE FEMALE: 5.18-26.53 NG/ML , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579709 ↗
• MalfunctionSep 25, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS GENERATED FOR A 9-YEAR-OLD FEMALE PATIENT WHO IS NOT PREGNANT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID 10276218 RESULT = 110 NG/ML, RESULT ON SIEMENS PLATFORM = 24 NG/ML. SAMPLE WAS INITIALLY RUN AT ANOTHER LABORATORY ON ANOTHER ALINITY. SAMPLE ID (B)(6). RESULT = 110 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144083 ↗
• MalfunctionSep 24, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR 9 YEAR OLD FEMALE PATIENT WHO IS NOT PREGNANT. THE SAMPLE WAS REPEATED USING THE SIEMENS METHOD WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) ALINITY RESULT = 110 NG/ML. SENT TO ANOTHER LAB ALINITY RESULT FOR SID (B)(6) = 110 NG/ML. SIEMENS RESULT = 24 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23133535 ↗
• MalfunctionSep 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN. THE CUSTOMER INITIALLY REPORTED ELEVATED QC AND THEN REPORTED AN ELEVATED PATIENT RESULT. THE CUSTOMER PROVIDED THE FOLLOWING DATA: THE PROLACTIN RESULT WAS 68 NG/ML., AND WHEN TESTED AT ANOTHER FACILITY WITH THE ROCHE PLATFORM, THE RESULT WAS 27 NG/ML. THERE WAS NO REPORTED IMPACT ON PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968371 ↗
• MalfunctionJun 2, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR ONE PATIENT. THE CUSTOMER OBSERVED A DIFFERENCE BETWEEN THE PLASMA AND SERUM SAMPLE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) - HEPARINIZED PLASMA TUBE = 42.63 NG/ML SID (B)(6) ¿ SERUM TUBE = 26.19 NG/ML PATIENT WAS DRAWN AGAIN WITH NEW SAMPLE SID (B)(6) - SERUM = 23.75 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124807 ↗
• MalfunctionJan 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR ONE 23-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023: PROLACTIN TESTED WITH THE CUSTOMER USING AN ARCHITECT AT (B)(6) WITH A RESULT OF 18.25 NG/ML (NORMAL). ON (B)(6) 2023, SHE RETURNED TO DO ALL HER HORMONAL TESTS AGAIN AND THIS TIME THE PROLACTIN WAS PROCESSED FOR SID (B)(6) ON THE ALINITY AT (B)(6) WITH A RESULT OF 78.26 NG/ML (ELEVATED). THIS SAMPLE WAS REPEATED AND GENERATED A RESULT OF 73.79 NG/ML (ELEVATED). THE PATIENT FOLLOWS UP WITH HER DOCTOR AND HE RECOMMENDS GOING TO ANOTHER LABORATORY AND OBTAINED A NORMAL RESULT. THE PATIENT GOES 3 DAYS LATER TO YET ANOTHER LAB TO HAVE A THIRD SAMPLE TESTED AND THE RESULT OBTAINED IS NORMAL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428444 ↗
• MalfunctionDec 4, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR MULTIPLE PATIENTS. THE SAMPLES WERE SENT TO ANOTHER LAB WITH CHEMILUMINESCENCE METHOD, AND THE RESULTS WERE LOWER. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: FEMALE ALINITY I PROLACTIN RESULT = 33.86 NG/ML; ANOTHER LAB¿S RESULT = 22.7 NG/ML. PATIENT 2: FEMALE ALINITY I PROLACTIN RESULT = 30.39 NG/ML; ANOTHER LAB¿S RESULT = 18.7 NG/ML. PATIENT 3: FEMALE ALINITY I PROLACTIN RESULT = 13.61 NG/ML; ANOTHER LAB¿S RESULT = 9.4 NG/ML. PATIENT 4: FEMALE ALINITY I PROLACTIN RESULT = 8.13 NG/ML; ANOTHER LAB¿S RESULT = 6.0 NG/ML. PATIENT 5: FEMALE ALINITY I PROLACTIN RESULT = 11.28 NG/ML; ANOTHER LAB¿S RESULT = 7.8 NG/ML. PATIENT 6: FEMALE ALINITY I PROLACTIN RESULT = 34.02 NG/ML; ANOTHER LAB¿S RESULT = 23.0 NG/ML. PATIENT 7: FEMALE ALINITY I PROLACTIN RESULT = 30.39 NG/ML; ANOTHER LAB¿S RESULT = 18.7 NG/ML. PATIENT 8: MALE ALINITY I PROLACTIN RESULT = 30.7 NG/ML; ANOTHER LAB¿S RESULT = 7.0 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18260263 ↗
• MalfunctionNov 13, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN AND PROVIDED THE FOLLOWING EXAMPLE DATA: FEMALE PATIENT DATA: CUSTOMER NORMAL VALUES ARE: 5.18 - 28 NG/ML. PATIENT 1 INITIAL RESULT WAS 28.95 NG/ML AND RETEST RESULT WAS 19.7 NG/ML. PATIENT 2 INITIAL RESULT WAS 65.15 NG/ML AND RETEST RESULT WAS 28.3 NG/ML. PATIENT 3 INITIAL RESULT WAS 26.72 NG/ML AND RETEST RESULT WAS 19.1 NG/ML. MALE DATA PROVIDED: CUSTOMER NORMAL VALUES ARE: 3.46 - 19.40 NG/ML. THE CUSTOMER TESTED 3 MALE SAMPLES THAT WERE FROM REPORTEDLY HEALTHY INDIVIDUALS AND OBTAINED THE FOLLOWING RESULTS: 23.9, 9.67, & 19.62. NO OTHER INFO AVAILABLE FOR THESE PATIENTS. THE CUSTOMER REPORTED LOT 52220UD00 AND LOT 53599UD00 WERE ON-BOARD THE ANALYZER WHEN THE DISCREPANT RESULTS WERE OBTAINED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120856 ↗
• MalfunctionNov 13, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN AND PROVIDED THE FOLLOWING EXAMPLE DATA: FEMALE PATIENT DATA: CUSTOMER NORMAL VALUES ARE: 5.18 - 28 NG/ML. PATIENT 1 INITIAL RESULT WAS 28.95 NG/ML AND RETEST RESULT WAS 19.7 NG/ML. PATIENT 2 INITIAL RESULT WAS 65.15 NG/ML AND RETEST RESULT WAS 28.3 NG/ML. PATIENT 3 INITIAL RESULT WAS 26.72 NG/ML AND RETEST RESULT WAS 19.1 NG/ML. MALE DATA PROVIDED: CUSTOMER NORMAL VALUES ARE: 3.46 - 19.40 NG/ML. THE CUSTOMER TESTED 3 MALE SAMPLES THAT WERE FROM REPORTEDLY HEALTHY INDIVIDUALS AND OBTAINED THE FOLLOWING RESULTS: 23.9, 9.67, & 19.62. NO OTHER INFO AVAILABLE FOR THESE PATIENTS. THE CUSTOMER REPORTED LOT 52220UD00 AND LOT 53599UD00 WERE ON-BOARD THE ANALYZER WHEN THE DISCREPANT RESULTS WERE OBTAINED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120832 ↗
• MalfunctionJul 20, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR A PATIENT. THE PATIENT PROVIDED ANOTHER SAMPLE THE NEXT DAY AND THE RESULT WAS NORMAL. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 108.78 TO 557.13 MIU/L. (B)(6) 2023 SAMPLE 1 INITIAL RESULT = 2671.55 MIU/L. RESULT AFTER PEG TREATMENT = 2300 MIU/L. SIEMENS RESULT = 1947.01 MIU/L. (B)(6) 2023 SAMPLE 2 INITIAL RESULT = 239.79 MIU/L; REPEATED RESULT = CONSISTENT WITH INITIAL RESULT. SIEMENS RESULT = 171.08 MIU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360305 ↗
• MalfunctionApr 10, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR A 40-YEAR-OLD FEMALE PATIENT WHEN COMPARING THE PATIENT¿S RESULTS WHEN TESTED AT OTHER LABORATORIES. THE FOLLOWING RESULTS WERE PROVIDED: AT THE CUSTOMER¿S SITE ON (B)(6) 2023: PROLACTIN RESULT = 106.9 NG/ML; REPEAT RESULT = 106.9 NG/ML. ON (B)(6) 2023: PROLACTIN RESULT = 106.1 NG/ML. REFERENCE RANGE: FEMALE = 5.18-26.53 NG/ML. CVS LAB ON (B)(6) 2023: PROLACTIN RESULT = 28.96 NG/ML. REFERENCE RANGE: FEMALE = 2.80-29.20 NG/ML; POST MENOPAUSE = 1.80-20.30 NG/ML; PREGNANT FEMALES: 9.70-208.50 NG/ML. PARDINI LAB ON (B)(6) 2023: PROLACTIN RESULT = 11.6 NG/ML; REPEAT RESULT POST DILUTION = 16.5 NG/ML; REPEAT RESULT POST TREATMENT WITH PEG (PROLACTIN CONCENTRATION AFTER TREATMENT WITH POLYETHYLENE GLYCOL) = 10.88 NG/ML. REFERENCE RANGE: FEMALE = 2.80-29.20 NG/ML; POST MENOPAUSE = 1.80-20.30 NG/ML. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED FOR PROLACTIN AT THE CUSTOMER¿S SITE. THE RESULT WAS 89.98 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710661 ↗
• MalfunctionApr 10, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I PROLACTIN RESULT ON A 20-YR OLD MALE PATIENT. RESULTS PROVIDED: (B)(6) 2022 SID (B)(6) PROLACTIN = 520 MU/L, ANOTHER LABORATORY = 14.7 UG/L (REFERENCE RANGE: 4.6-21.4 UG/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706957 ↗
• MalfunctionFeb 24, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED PROLACTIN RESULT FOR A 21-YEAR-OLD FEMALE WHEN COMPARED TO THE ROCHE METHOD. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2023. SID: (B)(6). INITIAL RESULT 41.10 NG /ML, SENT TO BIOMNIS REPEATED ON COBAS ROCHE RESULT = 22.2 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434660 ↗
• MalfunctionDec 19, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR 6 PATIENTS. THE CUSTOMER ALSO NOTICED A SHIFT UP IN BOTH LEVELS OF CONTROLS. THE SAMPLES WERE TESTED ON A DIFFERENT METHOD WHICH GENERATED LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: SAMPLE COLLECTION DATE: (B)(6) 2022, ALINITY RESULT = 52.44 NG/ML, CHEMILUMINESCENCE METHOD RESULT = 36.2 NG/ML, CHEMILUMINESCENCE REFERENCE VALUES: WOMEN: PRE-MENOPAUSE = 2.8 TO 29.2 NG/ML, POST-MENOPAUSE = 1.8 TO 20.3 NG/ML; MEN = 2.1 TO 17.7 NG/ML. PATIENT 2: ALINITY RESULTS PERFORMED ON (B)(6) 2022 = 80.11 NG/ML, 81.50 NG/ML, RESULT FROM HERMES PARDINI (HP) = 21.0 NG/ML. PATIENT 3: ALINITY RESULTS PERFORMED ON (B)(6) 2022 = 31.27 NG/ML, 30.56 NG/ML, RESULT FROM HERMES PARDINI (HP) = 9.3 NG/ML. PATIENT 4: SAMPLE COLLECTION DATE: (B)(6) 2022, ALINITY RESULT = 15.41 NG/ML, CHEMILUMINESCENCE METHOD RESULT = 9.7 NG/ML, CHEMILUMINESCENCE REFERENCE VALUES: WOMEN: PRE-MENOPAUSE = 2.8 TO 29.2 NG/ML, POST-MENOPAUSE = 1.8 TO 20.3 NG/ML; MEN = 2.1 TO 17.7 NG/ML. PATIENT 5: SAMPLE COLLECTION DATE: (B)(6) 2022, ALINITY RESULT = 35.06 NG/ML, CHEMILUMINESCENCE METHOD RESULT = 25.7 NG/ML, CHEMILUMINESCENCE REFERENCE VALUES: WOMEN:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003811 ↗