ARCHITECT 7K76-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380740105990), received between Jun 20, 2018 and Oct 23, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT PROLACTIN RESULT FOR A 48 YEAR OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED NORMAL RANGE: 5.18 TO 26.0 NG/ML): 04SEP2023 SID (B)(6) INITIAL RESULT (LOT 48500UD00) = 74.86 NG/ML. 25SEP2023 SID (B)(6) INITIAL RESULT (LOT 51258ED00) = 15.68 NG/ML. THE CUSTOMER IS QUESTIONING THE NEW SAMPLE THAT WAS COLLECTED ON (B)(6) 2023. THE PATIENT HAS A HISTORY OF A PITUITARY TUMOR AND PREVIOUS PROLACTIN RESULTS WERE IN THE RANGE OF 50 TO 70 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987528 ↗
• MalfunctionMar 6, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS WHICH QUESTIONED BY THE PHYSICIAN FOR ONE 45YRS OLD FEMALE PATIENT. THE RESULT PROVIDED WERE: ON (B)(6) 2023, 408 NG/ML / PREVIOUS HISTORY ON (B)(6) 21NG/ML; IN (B)(6), 32 NG/ML LABORATORY REFERENCE RANGE FOR PROLACTIN=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 16491356 ↗
• MalfunctionMay 20, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT PROLACTIN RESULTS FOR ONE SAMPLE THAT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE PERSISTENTLY GENERATED ARCHITECT PROLACTIN RESULTS BELOW 350 MIU/L. HOWEVER, PROLACTIN RESULT FROM ANOTHER CLINIC IS RECOVERING 600 TO 1000 MIU/L (UNKNOWN METHOD). THE PHYSICIAN IS INQUIRING ABOUT POTENTIAL NEGATIVE INTERFERENCE WITH THE ARCHITECT PROLACTIN ASSAY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462724 ↗
• MalfunctionSep 22, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020, SID: (B)(6), INITIAL ARCHITECT PROLACTIN RESULT=91.25 NG/ML /REPEATED USING CHEMILUMINESCENCE METHOD=25.65 NG/ML/REPEATED ON (B)(6) 2020, RESULT=92.49 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10569307 ↗
• MalfunctionApr 27, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT PROLACTIN RESULT FOR 1 SAMPLE WHEN COMPARED TO BECKMAN ANALYZER. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 5.18 TO 26.53 NG/ML): (B)(6) INITIAL RESULT = 130 NG/ML, REPEAT = 136.83 NG/ML, BECKMAN = 31.48 NG/ML (WITHIN THEIR REFERENCE RANGE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10003466 ↗
• MalfunctionApr 20, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS FOR 10 PATIENTS IN COMPARISON TO A SIEMENS METHOD. THE RESULTS PROVIDED WERE ONLY FOR 9 PATIENTS: ON 30MAR2020 ABBOTT RESULTS = 35.9NG/ML (REFERENCE RANGE 3.3-26.7NG/ML), SIEMENS RESULTS = 26.4NG/ML (REFERENCE RANGE 2.8-29.2NG/ML). ON (B)(6) 2020 THE CUSTOMER RETESTED 11 PATIENTS AND 8 OF THE ELEVEN HAD A SHIFT BETWEEN ARCHITECT AND SIEMENS OF >25%: PT#1 ARCH = 38.02 / SIEMENS = 29.32; PT#2 118.58 / 94.30; PT#4 ARCH = 38.29 / SIEMENS = 27.50; PT#5 ARCH = 42.09 / SIEMENS=28.30; PT#6 45.49 / 34.40; PT#8 ARCH = 34.81 / SIEMENS = 25.90; PT#9 57.78 / 32.60; PT#11 ARCH =34.68 / 22.48NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9977516 ↗
• MalfunctionJan 22, 2020High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT PROLACTIN RESULT OF 1205.58 MIU/ML WAS GENERATED FOR A PATIENT SAMPLE THAT TESTED AT 392 MIU/ML (WITHIN NORMAL RANGE) USING THE BECKMAN PROLACTIN METHOD. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617555 ↗
• MalfunctionNov 18, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULT FOR 1 SAMPLE WHEN COMPARED TO BECKMAN ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 857.65 MIU/L, REPEAT = 785.61 MIU/L (REFERENCE RANGE = 108.78 TO 557.13 MIU/L), BECKMAN = 278.31 UIU/ML (REFERENCE RANGE = 70.81 TO 566.46) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9334583 ↗
• MalfunctionDec 27, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS WHILE USING ARCHITECT PROLACTIN REAGENTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) (USING LOT 91424UI00) INITIAL 25.33 NG/ML, REPEAT 24.44 NG/ML. TEST USING PREVIOUS LOT (89425UI00) WAS HIGHER, SID (B)(6) 40.48 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8200511 ↗
• MalfunctionDec 20, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED ARCHITECT PROLACTIN RESULT FOR A (B)(6) FEMALE. SAMPLE ID (B)(6) GENERATED A RESULT OF 24.82 NG/ML ON A NEW LOT AND ON THE PREVIOUS LOT 44.83 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8184636 ↗
• MalfunctionNov 20, 2018Separation Failure; Separation Failure

  THE CUSTOMER OBSERVED A FALSELY ELEVATED PROLACTIN RESULT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL GREATER THAN 200, REPEATED 326, 14.40 NG/ML. PROGESTERONE RESULTS OF 16.04 AND 12.30 NG/ML WERE ALSO PROVIDED. THE PATIENT WAS ON THE FOLLOWING MEDICATIONS: LEVOTHYROXINE, CYCLOBENZAPRINE, DOMPERIDONE, GLUCOSAMINE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8092216 ↗
• MalfunctionJun 20, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED PROLACTIN RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) 2018: 108.0NG/ML / (B)(6) 2018: 140.0NG/ML. THE REFERENCE LAB TESTING GENERATED RESULTS: 100.61 / 102.71 / AND 101.66. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7619375 ↗