ARCHITECT 2P56-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380740161460), received between Jun 9, 2020 and May 20, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE (SN (B)(4) FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). INITIAL RESULT (SN (B)(4) 295 U/L, REPEATED ON ANOTHER INSTRUMENT (SN (B)(4) 683 AND 979 U/L SAME SAMPLE REPEATED AGAIN ON (C1601491) 303 AND 314 U/L, REPEATED ON (SN (B)(4) 309 U/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14464073 ↗
• MalfunctionMar 19, 2022High Test Results; High Test Results

  THE ACCOUNT GENERATED (B)(6) ARCHITECT LDH THAT REPEATED LOWER. A PATIENT SAMPLE GENERATED ARCHITECT LDH OF (B)(6) THAT REPEATED (B)(6). THE ACCOUNT LDH NORMAL EXPECTED RANGE IS 162 TO 243 U/L. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827305 ↗
• MalfunctionDec 22, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED LACTATE DEHYDROGENASE RESULT FOR ONE PATIENT ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT WAS 346.64, REPEATS ON OTHER ANALYZERS WERE 141.08, 142.67, AND 143.09 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13064148 ↗
• MalfunctionNov 3, 2021High Test Results; High Test Results

  THE CUSTOMER IDENTIFIED FALSELY ELEVATED LACTATE DEHYDROGENASE RESULTS. THE CUSTOMER USES THE REFERENCE RANGE 125U/L TO 243 U/L. THE FOLLOWING INFORMATION WAS PROVIDED: SAMPLE 1 INITIAL RESULT 218 U/L, REPEATED 349 U/L. SAMPLE 2 INITIAL RESULT 606 U/L, REPEATED 838 U/L. THE CUSTOMER NOTED THAT THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN AND HAVE NOT BEEN QUESTIONED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745826 ↗
• MalfunctionSep 27, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT FOR ONE PATIENT ON AN ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 125-220 U/L): INITIAL RESULT WAS 491, REPEATS WERE 200 AND 212 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532492 ↗
• MalfunctionMar 28, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR MULTIPLE SAMPLES. NO SPECIFIC PATIENT INFORMATION OR DATA OR COMPARISON DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580433 ↗
• MalfunctionJan 22, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 (B)(6) INITIAL = 1563.0U/L (NORMAL RANGE 125-220U/L) / RETEST = 147 AND 148U/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11215775 ↗
• MalfunctionJan 22, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT AFTER THE PHYSICIAN QUESTIONED THE RESULT. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE: 100 TO 250 U/L): THE PATIENT HAD TWO SAMPLES DRAWN ON (B)(6) 2020 AND (B)(6) 2020 WHICH GENERATED RESULTS OF 284 U/L AND 500 U/L. THE CUSTOMER DOES NOT KNOW WHICH RESULT GOES TO WHICH DATE. A THIRD SAMPLE WAS COLLECTED ON (B)(6) 2020 AND GENERATED RESULT OF 171 U/L WITH THE BECKMAN ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11213993 ↗
• MalfunctionDec 28, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS ON ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 SID (B)(6) INITIAL LDH= 371 U/L /REPEATED=582 U/L /REPEATED=366 U/L AND 380 U/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11080353 ↗
• MalfunctionDec 28, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 (B)(6) INITIAL LDH ON SERIAL NUMBER (B)(4) (NORMAL RANGE 125-220U/L) / RETEST ON SN (B)(4). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11077031 ↗
• MalfunctionSep 17, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 SID (B)(6) INITIAL = 570 U/L (NORMAL RANGE 120-240 U/L) / RETESTED = 193 AND 207 U/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10546937 ↗
• MalfunctionJul 17, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT FOR ONE PATIENT ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER'S REFERENCE RANGE IS 125-220 U/L): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2020, WAS 301.48 U/L, REPEATED ON AN ARCHITECT C8000 WAS 187.08 U/L. THE SAMPLE IS THEN RERUN ON THE C16000 ANALYZER AND THE RESULT WAS 178.14 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10292402 ↗
• MalfunctionJun 9, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 (B)(4) INITIAL = 466U/L / RETEST = 220 AND 206U/L (NORMAL RANGE 125-220U/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10132829 ↗