ARCHITECT 1G06-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 395 adverse event reports that list this exact device (DI 00380740000509), received between Aug 30, 2016 and Jun 2, 2026 — classified as 8 injuries, 387 malfunctions.

The most frequently reported specific device problem is “High Test Results” (189 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 395 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED SODIUM (NA) RESULT GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR A 27-YEAR-OLD MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER'S REFERENCE RANGE 133 - 145 MMOL/L): SAMPLE ID (B)(6), INITIAL RESULT = 168.40 MMOL/L, REPEAT RESULTS = 138.50 MMOL/L, 139.62 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364841 ↗
• MalfunctionJun 2, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED RESUTLS GENERATED FROM ARCHITECT ANALYZER (SN: (B)(6) AND PROVIDED THE FOLLOWING DATA ON 7 MAY 2026: SID: (B)(6) (54-YEAR-OLD MALE). INITIAL RESULT: CA+ RESULT WAS < 5 AND REPEAT RESULT WAS 9.2. CUSTOMER REFERENCE RANGE 8.5 -10.5MG/DL. DISCREPANT RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SID: (B)(6) (63-YEAR-OLD FEMALE). INITIAL RESULT: CO2 < 5MMOL/L. REPEATED ON ANOTHER ANALYZER (SN: (B)(6) AND REPEAT RESULT WAS 23MMOL/L. CUSTOMER REFERENCE RANGE: 20-29MMOL/L. CORRECTED REPORT WAS GENERATED FOR THIS SAMPLE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363427 ↗
• MalfunctionMay 15, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN ASSAY RESULTS GENERATED FROM ARCHITECT C8000 PROCESSING MODULE FOR A 58YRS OLD MALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2026 SID (B)(6) INITIAL=0.16 MG/DL /REPEATED=2.03 AND 2.05 MG/DL . LABORATORY REFERENCE RANGE FOR TOTAL BILIRUBIN=0.30 TO 1.20 MG/DL . THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191218 ↗
• MalfunctionApr 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE RESULTS ON THE ARCHITECT C8000 PROCESSING MODULE, SERIAL NUMBER: (B)(6). THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 INITIAL MAGNESIUM RESULT = >9 REPEAT RESULT = 1.8 MG/DL. PATIENT 2 INITIAL LACTIC ACID RESULT = 3 REPEAT RESULT = 8. NORMAL RANGES: MAG: 1.56-2.52 MG/DL. LACTIC ACID: 0.7-2.0 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959515 ↗
• MalfunctionApr 20, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: SID (B)(6), INITIAL=170 MMOL/L /REPEATED ON ARCHITECT (B)(6) =144 MMOL/L SID (B)(6), INITIAL=175 MMOL/L /REPEATED ON ARCHITECT (B)(6) =140 MMOL/L SID (B)(6), INITIAL=169 MMOL/L /REPEATED ON ARCHITECT (B)(6) =141 MMOL/L LABORATORY REFERENCE RANGE FOR SODIUM=136 TO 145 MMOL/L; < 120 MMOL/L AND > 159 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927263 ↗
• MalfunctionApr 10, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED RESULTS FOR MULTIPLE ASSAYS ON ARCHITECT C8000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: SID (B)(6): 49YRS OLD MALE: INITIAL SODIUM=115 MMOL/L /REPEATED ON C804465= 132 MMOL/L. ON (B)(6) 2026 SID (B)(6): 66YRS OLD MALE: INITIAL CALCIUM=5.7 MG/DL /REPEATED ON C804465=8.7 MG/DL. SID (B)(6): 58YRS OLD MALE =INITIAL SODIUM=114 MMOL/L /REPEATED ON C804465= 133 AND 135 MMOL/L. SID (B)(6): 38YRS OLD FEMALE =INITIAL SODIUM=119 MMOL/L /REPEATED ON C804465=137 MMOL/L. LABORATORY REFERENCE RANGE FOR SODIUM=136 TO 145 MMOL/L; CRITICAL= BELOW 120 AND ABOVE 160 MMOL/L; CALCIUM= 8.5 TO 10.5 MG/DL; CRITICAL= BELOW 6 AND ABOVE 13.0 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839683 ↗
• MalfunctionApr 7, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM2 & FALSELY DEPRESSED GLUCOSE RESULTS ON THE ARCHITECT C8000 PROCESSING MODULE FOR MULTIPLE PATIENTS. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING EXAMPLE WAS PROVIDED. CALCIUM: INITIAL RESULT =3.5 MG/DL, REPEAT RESULT =8.5 MG/DL. SID (B)(6); 65 YEARS OLD MALE, INITIAL RESULT= 3.7 MG/DL, REPEAT RESULT = 9.0 MG/DL, REPEAT RESULTS FROM ANOTHER PROCESSING MODULE =9.1 MG/DL. SID (B)(6); 87-YEAR-OLD MALE; INITIAL RESULT= 3.1 MG/DL, REPEAT RESULT =8.2 MG/DL. CUSTOMER REFERENCE RANGE IS (8.4 ¿ 10.4 MG/DL) GLUCOSE: (B)(6) 2026, SID (B)(6); 28 YEARS OLD FEMALE; INITIAL RESULT = 33 MG/DL, REPEAT RESULT= 78 MG/DL. THE CUSTOMER REFERENCE RANGE: (70 ¿ 100 MG/DL). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799870 ↗
• MalfunctionFeb 2, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED POTASSIUM RESULT FOR A 3-MONTH-OLD FEMALE PATIENT ON AN ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE FOR INFANTS IS 4.1-5.3 MMOL/L): SAMPLE ID (B)(6) INITIAL RESULT WAS 7.0, REPEAT RESULT, ON ANOTHER ANALYZER, WAS 5.3 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241087 ↗
• InjuryJan 19, 2026Unintended Movement

  UPDATE: ADDITIONAL INFORMATION WAS RECEIVED ON 23JAN2026. THE ARCHITECT C8000 PROCESSING MODULE WAS BEING MOVED ON ITS CASTERS WHEN THE TSS¿S FINGER BECAME CAUGHT BETWEEN THE INSTRUMENT AND THE RECEPTIONIST DESK IN THE HALLWAY. AT THE TIME OF THE INCIDENT, THE TSS WAS WEARING THE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE).

  Patient problems: Bone Fracture(s)

  MAUDE report 24108751 ↗
• MalfunctionDec 19, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED RESULTS GENERATED FROM ARCHITECT C8000. THE CUSTOMER PROVIDED THE FOLLOWING DATA: CREATININE RESULT WAS 1.38 MG/DL AND WHEN REPEATED ON ANOTHER ANALYZER THE RESULT WAS 3.99 MG/DL. PREVIOUS RESULT WAS 4.39 MG/DL. CUSTOMER NORMAL RANGE 0.72--1.25 MG/DL GLUCOSE INITIAL RESULT WAS <6 AND REPEAT RESULT WAS 120 (CUSTOMER NORMAL RANGE: 70-105 MG/DL) PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848131 ↗
• MalfunctionDec 11, 2025Smoking; Smoking

  THE CUSTOMER OBSERVED VISIBLE SMOKE COMING FROM THE ARCHITECT C8000 PROCESSING MODULE PRINTER WHILE IT WAS TROUBLESHOOTING THE PRINTER JAMS. THE POWER WAS REMOVED FROM THE PRINTER AND NO SIGNS OF FIRE WAS OBSERVED. THE CUSTOMER STOPPED USING THE PRINTER AND MENTIONED THE SMOKE WAS SMALL AND TEMPORARY AND LIMITED TO THE PRINTER. NO IMPACT TO PATIENT MANAGEMENT OR IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778495 ↗
• MalfunctionDec 9, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM AND CREATININE RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE ON TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) MAGNESIUM = 8.4 MG/DL, ANOTHER INSTRUMENT = 2.0 MG/DL (NORMAL RANGE: 1.8-2.4 MG/DL). (B)(6) 2025 SID (B)(6) CREATININE = 5.15 MG/DL, ANOTHER INSTRUMENT = 0.86 MG/DL (NORMAL RANGE: 0.50-1.30 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755436 ↗
• MalfunctionNov 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TOTAL BILIRUBIN GENERATED FROM ARCHITECT ANALYZER AND PROVIDED THE FOLLOWING DATA: THE CUSTOMER REPORTED THAT THEY WERE GETTING TOTAL BILIRUBIN RESULTS < 0.2 MG/DL AND UPON REPEAT THEY WERE GETTING ACTUAL NUMBERS. THE CUSTOMER COMMUNICATED THAT 40 PATIENTS' RESULTS REQUIRED CORRECTION. THE CUSTOMER CONFIRMED THAT THERE WAS NO IMPROPER TREATMENT DUE TO THE RESULTS. RESULT VALUES NOT PROVIDED, BUT THE FOLLOWING EXAMPLE WAS PROVIDED. ON (B)(6) 2025, SAMPLE ID (B)(6) INITIAL RESULT WAS < 0.2 MG/DL AND REPEAT RESULT WAS 0.3 MG/DL. CUSTOMER REFERENCE RANGE IS 0.2-1.3 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584561 ↗
• MalfunctionOct 8, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED SODIUM GENERATED FROM ARCHITECT ANALYZER AND PROVIDED THE FOLLOWING DATA: THE INITIAL RESULT WAS 105 MMOL/L AND THE REPEAT RESULT WAS 137 MMOL/L (CUSTOMER NORMAL RANGE 135-145 MMOL/L). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23244771 ↗
• MalfunctionSep 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT RESULTS GENERATED FROM ARCHITECT C8000 PROCESSING MODULE FOR SEVERAL PATIENTS. THE ONE RESULT EXAMPLE PROVIDED WERE: SID (B)(6) CREATININE INITIAL=1.65 MG/DL /REPEATED ON ANOTHER ARCHITECT C8000=2.11 MG/DL LABORATORY REFERENCE RANGE FOR 0 UP TO 12YRS=0.20 TO 0.70 MG/DL; 12 YRS UP TO UNSPECIFIED FEMALE=0.50 TO 1.10 MG/DL; MALE=0.50 TO 1.30 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23136537 ↗
• MalfunctionAug 26, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED GETTING DISCREPANT CALCIUM RESULTS GENERATED FROM ARCHITECT C8000. THE CUSTOMER PROVIDED THE FOLLOWING DATA: THE FIRST SAMPLE INITIAL RESULT WAS 4.9, AND REPEAT WAS 8.7. THE FIRST SAMPLE INITIAL RESULT WAS 5.8, AND REPEAT WAS 9.1. REFERENCE RANGE 8.4-10.2 MG/DL. CUSTOMER STATED THE RESULTS WERE NOT FILED TO PATIENT CHARTS. 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 22899207 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT RESULTS ON MULTIPLE ASSAYS GENERATED BY THE ARCHITECT (B)(6) PROCESSING MODULE FOR THREE PATIENTS. THE INITIAL RESULTS WERE NOT RELEASED FROM THE LABORATORY. THE SAMPLES WERE RETESTED ON ANOTHER INSTRUMENT, AND THOSE RESULTS WERE REPORTED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGES: MAGNESIUM: 1.6 TO 2.6 MG/DL CHLORIDE: 101 TO 110 MMOL/L CARBON DIOXIDE: 22 TO 29 MMOL/L POTASSIUM: 3.5 TO 5.0 MMOL/L PATIENT 1: SID: (B)(6) (69-YEAR-OLD, MALE) INITIAL MAGNESIUM RESULT = >9.5 MG/DL, REPEAT RESULTS (SAME INSTRUMENT) = 1.1 MG/DL, 2.2 MG/DL REPEAT RESULTS (ANOTHER INSTRUMENT) = 1.1 MG/DL (1:2 DILUTION), 2.2 MG/DL (UNDILUTED) PATIENT 2: SID: (B)(6) (74-YEAR-OLD, MALE) INITIAL MAGNESIUM RESULT = 8.2 MG/DL, REPEAT RESULT (ANOTHER INSTRUMENT) = 2.1 MG/DL PATIENT 3: SID: (B)(6) (62-YEAR-OL, FEMALE) INITIAL CHLORIDE RESULT = 102 MMOL/L, REPEAT RESULT (SAME INSTRUMENT) = 104 MMOL/L REPEAT CHLORIDE RESULT (ANOTHER INSTRUMENT) = 129 MMOL/L INITIAL CARBON DIOXIDE RESULT = 43 MMOL/L, REPEAT RESULT (ANOTHER INSTRUMENT) = 24 MMOL/L INITIAL POTASSIUM RESULT = 7.1 MMOL/L, REPEAT RESULT (ANOTHER INSTRUMENT) = 4.0 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22889969 ↗
• MalfunctionAug 25, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED RESULTS FOR MULTIPLE ASSAYS GENERATED ON ARCHITECT C8000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE ONE RESULT EXAMPLE PROVIDED WERE: INITIAL SODIUM=103 MMOL/L /REPEATED ON ANOTHER ANALYZER=140 MMOL/L, LABORATORY REFERENCE RANGE FOR SODIUM=136 TO 145 MMOL/L, THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884457 ↗
• MalfunctionAug 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS FOR ONE SAMPLE. THE CUSTOMER STATED THAT THERE WAS INSTRUMENT ERROR MESSAGE ¿1051 UNABLE TO CALCULATE RESULT, ABSORBANCE EXCEEDED OPTICAL LIMITS¿ AND THE INSTRUMENT WHEN TO AUTO-DILUTION AND THE RESULT WAS REPORTED OUT OF THE LAB. THE FOLLOWING RESULT WAS PROVIDED: TOTAL BILIRUBIN: AUTO-DILUTION RESULT THAT WAS REPORTED OUT WAS <0.1 MG/DL, RERUN WAS 0.5 MG/DL (REFERENCE RANGE: 0.1-1.2 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867659 ↗
• MalfunctionJul 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 0.7-0.91 MMOL/L): INITIAL MAGNESIUM RESULT = 3.5 MMOL/L REPEAT MAGNESIUM RESULT = 0.76 MMOL/L NO INCORRECT RESULTS WERE RELEASED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669080 ↗
• MalfunctionJul 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 1.6 TO 2.6 MG/DL): INITIAL RESULT = 7.6 MG/DL, REPEAT ON ANOTHER INSTRUMENT = 2.0 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579886 ↗
• MalfunctionJul 15, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE ON MULTIPLE PATIENTS. RESULTS PROVIDED: ALL INITIAL RESULTS WERE <0.10 MG/DL. SID REPEAT RESULT 3002539034 5.10 3002539004 2.84 3002538927 0.43 3002538905 0.21 3002538890 0.15 3002538790 0.25 3002538776 4.45 3002538738 0.34 3002538717 0.26 3002538715 0.38 3002538443 0.48 3002537992 0.27 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505373 ↗
• MalfunctionJun 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025. SID (B)(6) INITIAL SODIUM RESULT 116 MMOL/L, REPEATED 138 AND 139 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187982 ↗
• MalfunctionMay 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM AND CO2 RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6). INITIAL SODIUM RESULT 114 MMOL/L, REPEATED 132 AND 137 MMOL/L (REFERENCE RANGE IS 135-145 MMOL/L). INITIAL CO2 RESULT 21 MMOL/L, REPEATED 24 MMOL/L (REFERENCE RANGE 22-32 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061009 ↗
• MalfunctionMay 20, 2025Device Fell; Device Fell

  THE CUSTOMER OBSERVED THAT THE AIR SHOCK/COVER SUPPORT ON THE ARCHITECT C8000 PROCESSING MODULE IS WORN AND NOT HOLDING THE LID UP. THERE WERE NO INJURIES REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056237 ↗