ARCHITECT 3L82-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380740006006), received between Mar 23, 2017 and Oct 26, 2023 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED GLUCOSE RESULTS FOR ONE PATIENT SAMPLE WHEN RUNNING ON THE ARCHITECT C4000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023 SID (B)(6): INITIAL GLUCOSE RESULT = 636 MG/DL; RERUN RESULT = 635 MG/DL (REFERENCE RANGE: 70-99 MG/DL; CRITICAL RANGE: > 400 MG/DL) THE DOCTOR QUESTIONED THE RESULT, AND THE CUSTOMER RERAN THE SAMPLE ON AN ALTERNATE ARCHITECT AND GENERATED A RESULT OF 209 MG/DL. THE SAMPLE WAS THEN RERUN ON THE ORIGINAL INSTRUMENT AND GENERATED A RESULT OF 210 MG/DL. THE CUSTOMER STATED THE QC WAS IN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017264 ↗
• MalfunctionNov 4, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED GLUCOSE RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 (B)(6) INITIAL = 282.7MG/DL / REPEATED ON (B)(6) 2019 = 92MG/DL / HBA1C = 5.5; NEW SAMPLE ON (B)(6) 2019 (B)(6)= 82.2MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9272840 ↗
• MalfunctionOct 15, 2019Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED GLUCOSE RESULTS ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 1.13, REPEAT 8.92 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9193497 ↗
• MalfunctionOct 8, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT GLUCOSE RESULT FO A (B)(6) YEAR OLD MALE PATIENT. SAMPLE ID (B)(6) GENERATED 19.91 MMOL/L (358.74 MG/DL) AND RETEST OF 4.82 MMOL/L (86.45 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9166317 ↗
• InjuryNov 20, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED GLUCOSE RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: T0 169.1 MG/DL 92.1 MG/DL; T1 240.3 MG/DL 144 MG/DL; T2 216 MG/DL, 101.2 MG/DL. DUE TO IMPRECISE GLUCOSE RESULTS, THE DOCTOR STARTED A TREATMENT BASED ON THE FIRST RESULT, WHICH TURNED OUT TO BE INAPPROPRIATE, CAUSING SIGNIFICANT HYPOGLYCEMIA IN THE PATIENT. NO FURTHER DETAILS REGARDING THE TREATMENT OR HOW THE PATIENT IS DOING, ARE YET AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8090294 ↗
• MalfunctionOct 30, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED GLUCOSE RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL = 360MG/DL / REPEAT WITH A NEW SAMPLE WAS NORMAL (APPROXIMATELY 90MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8020374 ↗
• MalfunctionMay 1, 2018Incorrect Or Inadequate Test Results; Low Test Results; Incorrect Or Inadequate Test Results; Low Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY DEPRESSED GLUCOSE RESULTS WHILE USING CLINICAL CHEMISTRY GLUCOSE REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR THE SAME PATIENT: SID: (B)(6) (SERUM) INITIAL 47 MG/DL, REPEAT 47 MG/DL. GLUCOMETER READING 15 MINUTES EARLIER WAS HIGHER, 158 MG/DL. PREVIOUS RESULTS FOR THE PATIENT USING THE CLINICAL CHEMISTRY GLUCOSE METHOD RANGED FROM 44 TO 47 MG/DL. THE CUSTOMER STATED THE PATIENT TAKES VITAMIN D, A MULTIVITAMIN, FENLASAXINE (150 MG, 2 TABLETS PER DAY) AND N-ACETYL-L-CYSTEINE (600 MG, 4 TABLETS PER DAY). NO CHANGE TO MEDICATION WAS REPORTED DUE TO THE FALSELY DEPRESSED GLUCOSE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7478071 ↗
• MalfunctionApr 6, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED GLUCOSE RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL = 360MG/DL / REPEAT WITH A NEW SAMPLE WAS NORMAL (APPROXIMATELY 90MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7402703 ↗
• MalfunctionJun 13, 2017Low Test Results; Low Test Results

  THE ACCOUNT GENERATED A FALSELY DEPRESSED ARCHITECT GLUCOSE OF 10 MG/DL ON A SAMPLE THAT REPEATED 143 MG/DL ON ANOTHER ANALYZER. THE SAMPLE WAS PROCESSED AGAIN ON THE ORIGINAL ANALYZER WITH ARCHITECT GLUCOSE OF 145 MG/DL. NO SPECIFIC PATIENT INFORMATION OR IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6637410 ↗
• MalfunctionMay 29, 2017Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED CLINCIAL CHEMISTRY GLUCOSE RESULT WHILE USING THE ARCHITECT C4000 ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING DATA: INITIAL RESULT: 709 MG/DL, RETEST 72 MG/DL. THE PHYSICIAN QUESTIONED THE RESULT OF 72 WHICH DID NOT ALIGN WITH THE PATIENT DIAGNOSIS AND PATHOLOGY (SPECIFIC DETAILS NOT PROVIDED). A SECOND SPECIMEN WAS DRAWN AND GENERATED RESULT AS EXPECTED; 707 MG/DL AND 698 MG/DL THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6596501 ↗
• MalfunctionMay 19, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED GLUCOSE RESULT WHILE USING THE CLINICAL CHEMISTRY GLUCOSE ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR A NEWBORN PATIENT ON (B)(6) 2017; INITIAL RESULT (USING A GLUCOSE METER) 2.1 MMOL/L (37.84 MG/DL) A NEW SPECIMEN WAS COLLECTED FROM THE SAME PUNCTURE AND TESTED WAS COMPLETED FOR CONFIRMATION USING THE CLINICAL CHEMISTRY GLUCOSE ASSAY: 3.6 MMOL/L (64.68 MG/DL) THE RESULT OF 3.6 MOL/L WAS AUTOVERIFIED AND A RESULT OF 2.1 MMOL/L WAS GENERATED. THE SPECIMEN WAS TESTED A THIRD TIME AND A RESULT OF 2.1 MMOL/L WAS GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578363 ↗
• MalfunctionMay 10, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED DISCREPANT FALSELY LOW GLUCOSE RESULTS GENERATED USING THE CLINICAL CHEMISTRY GLUCOSE REAGENTS. THE FOLLOWING DATA WAS PROVIDED AND WAS GENERATED IN (B)(6) 2016. INITIAL 0.19 G/L (19 MG/DL); REPEAT 1.75 G/L (175 MG/DL); REPEATED AS PART OF REPRODUCIBILITY, 10 REPLICATES RANGED FROM 1.26 TO 1.87 G/L (126 TO 187 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6559117 ↗
• MalfunctionApr 17, 2017High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSELY ELEVATED ARCHITECT GLUCOSE RESULTS ON 3 PATIENT SAMPLES PROCESSED ON THE ARCHITECT C4000 ANALYZER. ID (B)(6) GENERATED ARCHITECT GLUCOSE OF 223 MG/DL THAT REPEATED 77 MG/DL. ID (B)(6) GENERATED ARCHITECT GLUCOSE OF 384 MG/DL THAT REPEATED 74 MG/DL. ID (B)(6) GENERATED ARCHITECT GLUCOSE 219 MG/DL THAT REPEATED 98 MG/DL. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6498489 ↗
• MalfunctionMar 23, 2017Low Test Results; Low Test Results

  THE ACCOUNT GENERATED A FALSELY DECREASED ARCHITECT GLUCOSE OF 65 MG/DL ON A PATIENT THAT INITIALLY GENERATED 537 MG/DL. GLUCOMETER CHECK WAS 460 AND RETEST OF THE SAMPLE WAS 525 MG/DL. A NEW SPECIMEN GENERATED SIMILAR RESULTS OF 461 MG/DL ON THE ARCHITECT AND GLUCOMETER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6428323 ↗