ARCHITECT 7K76-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00380740014865), received between Apr 11, 2018 and Feb 17, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “High Test Results” (33 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR TWO FEMALE PATIENTS. THESE RESULTS WERE INCONSISTENT WITH THE RESULTS PRODUCED BY OTHER PLATFORMS. THE FOLLOWING DATA WERE PROVIDED: CUSTOMER¿S NORMAL RANGE FOR WOMEN: 5.18 TO 26.53 NG/ML. PATIENT 1 (42-YEAR-OLD): SAMPLE ID: (B)(6) FIRST BLOOD DRAW: ARCHITECT PROLACTIN RESULT = 27 NG/ML, ROCHE PLATFORM RESULT = 13 NG/ML AND 13 NG/ML. (B)(6) 2025 (SECOND BLOOD DRAW): ARCHITECT PROLACTIN RESULT = 22.91 NG/ML CHEMILUMINESCENCE METHOD = 13 NG/ML. PATIENT¿S HISTORICAL RESULT = 44 NG/ML. PATIENT 2 (47-YEAR-OLD): SAMPLE ID: (B)(6) ON (B)(6) 2025 (FIRST BLOOD DRAW): ARCHITECT PROLACTIN RESULT = 47.39 NG/ML ROCHE PLATFORM RESULT = 16 NG/ML . ON (B)(6) 2025 (SECOND BLOOD DRAW): ARCHITECT PROLACTIN RESULT = 48.42 NG/ML, CHEMILUMINESCENCE METHOD = 13 NG/ML, MAGLUMI PLATFORM RESULT = 15 NG/ML. PATIENT¿S HISTORICAL RESULT = 44 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367656 ↗
• MalfunctionJan 19, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT PROLACTIN RESULTS FOR ONE FEMALE PATIENT. THE WAS REPEATED WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: ARCHITECT INITIAL PROLACTIN RESULT PROCESSED ON (B)(6) 2026 = <12.6 MIU/L REPEAT RESULT = 210 MIU/L SAMPLE SENT TO ANOTHER LABORATORY (METHOD UNKNOWN) RESULT = >200 MIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24110235 ↗
• MalfunctionOct 20, 2025High Test Results; High Test Results

  ON 01DEC2025, ADDITIONAL PATIENT RESULTS WERE PROVIDED BY THE CUSTOMER FOR FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS. THE CUSTOMER SENT TWO PATIENTS TO BE RERUN AT CERBA. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID: (B)(6): ARCHITECT PROLACTIN RESULT: 31.93 NG/ML (REFERENCE RANGE: 3.46-19.40 NG/ML). CERBA PROLACTIN RESULT: 17 NG/ML (NORMAL RANGE: < 20 NG/ML). ON (B)(6) 2025, SID: (B)(6): ARCHITECT PROLACTIN RESULT: 23.64 NG/ML (REFERENCE RANGE: 3.46-19.40 NG/ML). CERBA PROLACTIN RESULT: 14 NG/ML (NORMAL RANGE: < 20 NG/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335547 ↗
• MalfunctionMay 28, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER FOR MULTIPLE PATIENTS. THE INITIAL RESULTS WERE NOT RELEASED OUT OF THE LAB. THE ISSUE WAS NOT RESOLVED AFTER RECALIBRATING THE REAGENT, AND THE PROLACTIN RESULTS WERE STILL ELEVATED. THE PROLACTIN REAGENT WAS CALIBRATED ON A SECOND ANALYZER WHICH GENERATED SIMILAR RESULTS. THE CUSTOMER SENT THE SAMPLES TO A SUPPORT LABORATORY, THOSE SAME SAMPLES GENERATED LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): PRO-SANGUE RESULTS = 27.38 / 27.45 NG/ML; SUPPORT LAB 1 RESULT = 20.04 NG/ML. SID (B)(6): PRO-SANGUE RESULTS = 67.20 / 74.31 / 71.39 NG/ML; SUPPORT LAB 1 RESULT = 17.29 NG/ML; SUPPORT LAB 2 RESULT = 14.6 NG/ML. SID (B)(6): PRO-SANGUE RESULT = 41.5 NG/ML; SUPPORT LAB 2 RESULT = 28.1 NG/ML. THE CUSTOMER¿S (PRO-SANGUE) REFERENCE RANGE FOR PROLACTIN IS 1.9 TO 27.00 NG/ML. THE SUPPORT LAB REFERENCE RANGE FOR PROLACTIN IS 2.80 TO 29.20 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097437 ↗
• MalfunctionNov 20, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS SENT OUT FOR A RETEST AND THE RESULT WAS NORMAL. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 4 TO 26 NG/ML (B)(6) 2024 SID (B)(6) ARCHITECT PROLACTIN RESULT = 33.69 NG/ML RETEST RESULT FROM ANOTHER LAB = 24.5 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736352 ↗
• MalfunctionNov 20, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS SENT OUT FOR A RETEST AND THE RESULT WAS NORMAL. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 4 TO 26 NG/ML. (B)(6)2024 SID (B)(6) ARCHITECT PROLACTIN RESULT = 33.69 NG/ML. RETEST RESULT FROM ANOTHER LAB = 24.5 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736159 ↗
• MalfunctionMay 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT PROLACTIN AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT (ID: (B)(6) ): ON 4 APR 24, THE ARCHITECT PROLACTIN WAS 50.84 NG/ML. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND GENERATED A PROLACTIN RESULT OF 20 NG/ML (ELECTROCHEMILUMINESCENCE METHOD). THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND GENERATED A PROLACTIN RESULT OF 13 NG/ML (CHEMILUMINESCENCE METHOD). 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 19280664 ↗
• MalfunctionMay 1, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT PROLACTIN RESULT GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 1.2 - 29.9 NG/ML). (B)(6) 2024 SAMPLE ID 10507185 INITIAL RESULT = 149.22 NG/ML, SAME SAMPLE REPEATED ON (B)(6) 2024 AND RESULT = <0.6 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226371 ↗
• MalfunctionFeb 23, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: PATIENT 2 FEMALE (CUSTOMER¿S REFERENCE RANGE 1.2 - 29.9 NG/ML). SAMPLE ID (B)(6) INITIAL RESULT = 49.41 NG/ML, RESULT AT ANOTHER LABORATORY = 29.2 NG/ML (REFERENCE RANGE ADULT FEMALE 2.8- 29.2 NG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773276 ↗
• MalfunctionDec 28, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT PROLACTIN AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: CUSTOMER REFERENCE RANGE IS > 20 NG/ML. ON (B)(6) 2023 SAMPLE ID: 2312071010 GENERATED A RESULT OF 141 NG/ML ON (B)(6) 2023 SAMPLE ID: 2310131045 GENERATED A RESULT OF 176 NG/ML. IT WAS REPORTED THAT THE PATIENT WAS RETESTED AT ANOTHER LABORATORY, WHICH GENERATED A RESULT LESS THAN 20 PATIENT NORMAL ACCORDING TO THE ENDOCRINOLOGIST AND THERE WAS NOTHING TO REPORT ON THE MRI. IT WAS REPORTED THAT THE PATIENT HAD THE MRI DUE TO THE PROLACTIN RESULTS. IT IS UNKNOWN IF THE PATIENT HAD IV CONTRAST FOR THE MRI. THE CUSTOMER CONFIRMED THAT THERE WAS NO REPORTED PATIENT HARM AND THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407483 ↗
• MalfunctionAug 21, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS WHICH QUESTIONED BY THE PHYSICIAN ON MULTIPLE PATIENTS. THE CUSTOMER SENT OUT MULTIPLE TIMES SPECIMENS AT QUEST DIAGNOSTIC LABORATORY FOR REPEAT ON PROLACTIN AND MONOMERIC PROLACTIN WHICH ARE NORMAL ACCORDING TO QUEST REFERENCE RANGE. THE RESULT PROVIDED WERE: PATIENT 1 81YRS OLD MALE: ON 02AUG2022 AT QUEST TOTAL PROLACTIN=11.2 NG/ML; MONOMERIC PROLACTIN=5.2 NG/ML 20AUG2019 ARCHITECT PROLACTIN RESULT= 42.05 NG/ML /SENT SAMPLE TO QUEST RESULTS: TOTAL PROLACTIN= 12.4 NG/ML; MONOMERIC PROLACTIN= 4.0 NG/ML; PREVIOUS HISTORY: 21AUG2018 ARCHITECT PROLACTIN RESULT= 71.71 NG/ML /SENT SAMPLE TO QUEST RESULTS: TOTAL PROLACTIN= 16.4 NG/ML; MONOMERIC PROLACTIN= 4.6NG/ML /ON 12FEB2015=57.04 NG/ML/ON 30JUN2015=93.82 NG/ML /ON 17SEP2015=29.19 NG/ML /ON 28OCT2015= 43.92 NG/ML /ON 04DEC2015=7.36 NG/ML /ON 08JUN2016=12.82 /ON 02SEP2016=62.82 NG/ML /ON 10NOV2016=5.59 NG/ML / ON 22MAY2017= 4.62 NG/ML /ON 28NOV2017=7.77 NG/ML /ON 09MAY2018=28.43 NG/ML /30MAY2018=25.89 NG/ML /21AUG2018=71.71 NG/ML /ON 18SEP2018 AT QUEST TOTAL PROLACTIN= 16.4 NG/ML; PROLACTIN,MONOMERIC=4.6 NG/ML PATIENT 2: 64YRS OLD MALE: ARCHITECT PROLACTIN RESULT ON 07J

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17589650 ↗
• MalfunctionMay 30, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT PROLACTIN RESULT FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE 3-29 NG/ML): SAMPLE ID (B)(6) 03MAY2023 INITIAL RESULT = 166.14 NG/ML, 08MAY2023 RESULT AT A DIFFERENT LAB = 7.30 NG/ML. SAME PATIENT, NEW SAMPLE OBTAINED 10MAY2023 AND RESULT = 3.16 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021107 ↗
• MalfunctionFeb 23, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULT FOR THREE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (3-29 NG/ML-NORMAL RANGE): PATIENT 1 SID (B)(6) (FEMALE) PROLACTIN INITIAL 32.84 NG/ML, REPEATED IN ANOTHER LAB (CHEMILUMINESCENCE) 13.0 NG/ML (PATIENT 2 SID (B)(6) (MALE) PROLACTIN INITIAL 47.73 NG/ML, REPEATED IN ANOTHER LAB (CHEMILUMINESCENCE) 11.2 NG/ML PATIENT 3 SID (B)(6) (WOMAN) PROLACTIN INITIAL 62.8 NG/ML, REPEATED IN ANOTHER LAB (CHEMILUMINESCENCE) 39.3 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427898 ↗
• MalfunctionNov 9, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS WHICH QUESTIONED BY THE PHYSICIAN FOR MULTIPLE PATIENTS. THE ONE RESULT EXAMPLE PROVIDED WERE: SID (B)(6) (FEMALE, 43 YEARS OLD): ON (B)(6) 2022 INITIAL= 71.48 NG/ML (LABORATORY REFERENCE RANGE FOR PROLACTIN= 1 TO 25 NG/ML) /SENT SPECIMEN TO QUEST LABORATORY =14 (REFERENCE RANGE 3 TO 30) AND MONOMERIC PROLACTIN=4.8 (REFERENCE RANGE 3.2 TO 25.2) /REDRAWN THE PATIENT ON (B)(6) 2022 SENT TO QUEST=18.4 /ON MONOMERIC=5.2 THE SPECIMEN TESTED FOR HAMA: <6 NG/ML AND HETEROPHILE AB: NEGATIVE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758983 ↗
• MalfunctionSep 22, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS ON ONE MALE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=82.3 NG/ML /AFTER CALIBRATION=32.1 NG/ML /MIDRAY PROLACTIN=26.6 NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463643 ↗
• MalfunctionAug 15, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT PROLACTIN RESULT FOR A PATIENT SAMPLE. SID (B)(6). INITIAL RESULT: 53.07 NG/ML, REPEAT RESULT: 52.95 NG/ML (REFERENCE RANGE FEMALE: 5.18-26.53 NG/ML) THE LABORATORY DOES NOT CARRY OUT THE PEG METHOD TO EXCLUDE INTERFERENCE WITH MACROPROLACTIN. THE CUSTOMER SENT THE SAMPLE OUT TO ANOTHER LABORATORY THAT USES THE CENTAUR CMIA TECHNIQUE AND OBTAINED A RESULT OF 19.9 NG/ML (REFERENCE RANGE: 2.7-29.0 NG/ML) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15226051 ↗
• MalfunctionMay 10, 2022High Test Results; High Test Results

  THE CUSTOMER STATES FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS WHICH QUESTIONED BY PHYSICIAN ON ONE (B)(6) OLD FEMALE PATIENT. THIS PATIENT HAD PROLACTIN PERFORMED ON ARCHITECT FEW TIMES; SID (B)(6) IN 2020 TO 2022, RESULTS RANGING BETWEEN 70 TO 100 UG/L. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) =96.2 UG/L CUSTOMER REFERENCE RANGE=5.2 TO 27 UG/L /SEND OUT TO IN COMMON LAB=31 UG/L REFERENCE RANGE=< 25 UG/L; MACROPROLACTIN=0.421 POSITIVE > 0.4 SID (B)(6) =106.4 G/L /ON (B)(6) 2021 SID (B)(6)= 87.4 UG/L /(B)(6)2022 SID (B)(6) = 69.5 UG/L /ON (B)(6) 2020 SID (B)(6) = 76.7 UG/L /ON (B)(6) 2020 SID (B)(6) = 85.9 UG/L. THE CUSTOMER HAD MRI SCAN WITH IV CONTRAST FOR PITUITARY DUE TO FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS AND MULTIPLE VISITS TO ENDOCRINE CLINIC AND REPEATING BLOOD TESTING. PER ARCHITECT PROLACTIN PACKAGE INSERT: PROLACTIN MAY EXIST IN ALTERNATE STRUCTURAL FORMS (E.G., MACROPROLACTIN)19-22 WHICH MAY EXHIBIT VARIABLE LEVELS OF PHYSIOLOGICAL ACTIVITY. IN PATIENTS WITH ELEVATED PROLACTIN RESULTS, ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS. NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347235 ↗
• MalfunctionMay 4, 2022High Test Results; High Test Results

  THE CUSTOMER QUESTIONED ARCHITECT PROLACTIN RESULTS FOR ONE PATIENT. THE CUSTOMER NOTED THE PATIENT WAS TESTED 4-5 TIMES FROM 2020- 2022 WITH PROLACTIN RANGING FROM 70-100 NG/L AND SIDS (B)(6). AT ONE POINT THE CUSTOMER REPORTED RESULT OF 96.2 OUT OF THE LAB- WHILE TOTAL PROLACTIN ON THE SAME SAMPLE FROM ANOTHER LAB WAS 31NG/L (EXTERNAL LAB HAS A SIMILAR REF RANGE) WITH A MACROPROLACTIN RESULT OF 0.421 (POSITIVE MACROPROLACTIN STATED AT >0.4) . THE PATIENT IS ASYMPTOMATIC BUT HAS BEEN SUBJECTED TO PITUITARY IMAGING (MRI) WITH CONTRAST DUE TO THE RESULTS, WHICH DIDN¿T SHOW ANY ANOMALIES, AND HAS BEEN FOLLOWED UP ON NUMEROUS OCCASIONS BY THE ENDOCRINE CLINIC. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS FROM THE MRI AND WAS NOTED AS HAVING NO SYMPTOMS OF HYPERPROLACTINEMIA AT ALL. THE HIGH PROLACTIN WAS PICKED UP INCIDENTALLY ON LABS ORDERED BY PRIMARY CARE SEVERAL YEARS AGO. THE PATIENT WAS NOTED TO HAVE SOME FEATURES OF PCOS, AND PER THE PHYSICIAN THE MILDLY ELEVATED PROLACTIN FROM ICL WOULD BE MUCH MORE IN KEEPING WITH THAT PRESENTATION RATHER THAN THE VALUES BETWEEN 70-100 UG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282371 ↗
• MalfunctionMar 28, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN ON (B)(6) YEAR OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL= > 100 NG/ML /REFERENCE LAB RESULT=28.66 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13933308 ↗
• MalfunctionMar 23, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS WERE GENERATED FOR A FEMALE PATIENT. THE INITIAL RESULT WAS 120 NG/ML AND THE REPEAT RESULT WAS 124 NG/ML (ABOVE THE NORMAL RANGE). THE EXPECTED RANGE FOR FEMALES PER THE ARCHITECT PROLACTIN PACKAGE INSERT IS 5.18 - 26.53 NG/ML. WHEN TESTED ON THE ROCHE PLATFORM AT ANOTHER HOSPITAL, THE RESULT WAS WITHIN THE NORMAL RANGE (EXACT VALUE NOT PROVIDED). IT IS SUSPECTED THE FALSELY ELEVATED RESULTS ARE DUE TO AN INTERFERING SUBSTANCE IN THE SAMPLE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862720 ↗
• MalfunctionJul 7, 2021High Test Results; High Test Results

  ON (B)(6) 2021 THE CUSTOMER PROVIDED TWO ADDITIONAL FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS: SAMPLE 3: ARCHITECT 168.67, 158.94 AND 163.63 NG/ML; RETEST AT TWO ALTERNATE LABS (CHEMILUMINESCENCE TECHNIQUE) 26.16 AND 23 NG/ML SAMPLE 4: ARCHITECT 200 AND 237.91 NG/ML; RETEST AT AN ALTERNATE LAB (CHEMILUMINESCENCE TECHNIQUE) 131.68 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129714 ↗
• MalfunctionJun 9, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULT ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL=90.17 NG/ML /REPEATED AT OTHER FACILITY ON CHEMILUMINESCENCE METHODOLOGY=20.40 NG/ML LABORATORY NORMAL RANGE FOR WOMEN=5.18 TO 26.53 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967692 ↗
• MalfunctionMay 5, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT PROLACTIN RESULT ON A PATIENT BORN IN (B)(6) DIAGNOSED WITH A PITUITARY ADENOMA. RESULTS PROVIDED: (B)(6) 2021 = 195.20 NG/ML; ANOTHER LABORATORY TESTED NORMAL; PATIENT TYPICALLY GENERATES A RESULT AROUND 100 NG/ML (REFERENCE RANGE: 5.18-26 NG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777540 ↗
• MalfunctionOct 8, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT PROLACTIN RESULTS ON A 41-YEAR-OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: ABBOTT RESULT = 93.86 NG/ML (REFERENCE RANGE WAS 5.18 TO 26.53 NG/ML), THE BECKMAN¿S RESULT WAS 25.63 NG/ML (REFERENCE RANGE 3.34 TO 26.72 NG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10648982 ↗
• MalfunctionJul 28, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT PROLACTIN RESULT FOR A 15 YEAR OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2020 INITIAL RESULT = 54.2 NG/ML, REPEAT WITH ANOTHER METHOD = 20.5 NG/ML ADDITIONAL LABORATORY DATA WAS PROVIDED: FSH = 1.93, E2 = 64, LH = 0.70. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10335330 ↗