ARCHITECT 2P56-21Recalls & reported problems
Abbott Laboratories · Lactate Dehydrogenase · Class 2
Quick summary
This is Abbott's ARCHITECT lactate dehydrogenase (LDH) assay, a lab test run on the company's automated analyzers. The 51 reports mostly describe results that came back falsely high, sometimes many times the normal range, while repeat testing of the same sample gave normal results. No deaths and no injuries were reported, and the reports describe no added impact on patient care. No recalls name this assay.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00380740004033), received between Sep 6, 2016 and Dec 2, 2021 — classified as 51 malfunctions.
The most frequently reported specific device problem is “High Test Results” (51 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
Device problems
- High Test Results51
Patient problems
- No Known Impact Or Consequence To Patient45
- No Consequences Or Impact To Patient3
- No Code Available2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2021High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 125 TO 243 U/L): SID (B)(6) INITIAL RESULT WAS 893 U/L, NO REPEAT RESULT PROVIDED. SID (B)(6) INITIAL RESULT WAS 872 U/L, NO REPEAT RESULT PROVIDED. SID (B)(6) INITIAL RESULT WAS 905 U/L, NO REPEAT RESULT PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12915576 ↗MalfunctionAug 10, 2020High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 SID (B)(6) INITIAL = >665U/L (NORMAL RANGE 125-200U/L); 1:1 = 220 / 1:10 = 186U/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10385217 ↗MalfunctionJul 8, 2020High Test Results; High Test Results
ON (B)(6) 2020 CUSTOMER PROVIDE ADDITIONAL INFORMATION REGARDING THEIR STATEMENT OF FALSE ELEVATED ARCHITECT LACTATE DEHYDROGENASE (LDH) ASSAY RESULTS FOR 2 PATIENTS. THE CUSTOMER PROVIDED: PT#1: (B)(6) YEAR OLD FEMALE: INITIAL = 195 U/L; REPEAT 714, 200 U/L; PT#2: (B)(6) YEAR OLD MALE: INITIAL = 244 U/L; REPEAT 331 U/L, 276 U/L (REF RANGE: 140 TO 280 U/L). IT WAS ALSO ADDED THAT ALL RESULTS ARE FROM THE SAME SAMPLE MEASURED WITHOUT FURTHER SAMPLE TREATMENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10248374 ↗MalfunctionJun 19, 2020High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS ON ONE PATIENT FROM AN ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2020, WAS 2441 U/L, WHICH WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE MEDICAL PROVIDER. WHEN THE SAMPLE WAS REPEATED THE RESULTS WERE 308, 369, 359, AND 312 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10176543 ↗MalfunctionApr 1, 2020High Test Results; High Test Results
THE CUSTOMER REPORTED A FALSE ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT WHEN PROCESSING ON THE ARCHITECT C16000. THE INITIAL RESULT WAS 514 U/L AND RETEST WAS 198 U/L. RETESTING ON ANOTHER INSTRUMENT YIELDED RESULTS OF 195, 7, AND 197 U/L. THE CUSTOMER USES A REFERENCE RANGE OF 125-220 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9910387 ↗MalfunctionMar 25, 2020High Test Results; High Test Results
THE CUSTOMER OBSERVED ERRATIC ARCHITECT LACTATE DEHYDROGENASE (LDH) ASSAY RESULTS FOR ONE PATIENT SAMPLE. SAMPLE ID (B)(6) WAS TESTED MULTIPLE TIMES ACROSS TWO ANALYZERS. THE SAMPLE GENERATED ELEVATED RESULTS OF 295.96 AND 258.68 U/L AND NORMAL RESULTS OF 210.55 U/L, 199.29 AND 187.71 U/L. THE CUSTOMERS REFERENCE RANGE IS 125 TO 220 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9877741 ↗MalfunctionMar 6, 2020High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) INITIAL RESULT = 1319 U/L, REPEAT = 176 U/L, REFERENCE RANGE = 125 U/L TO 243 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9801967 ↗MalfunctionDec 16, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED A FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 976, REPEATS 179, 180. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9474001 ↗MalfunctionSep 25, 2019High Test Results; High Test Results
THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT LACTATE DEHYDROGENASE RESULT. SAMPLE ID (B)(6) GENERATED 470 AND RETEST OF 89 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9119103 ↗MalfunctionSep 23, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED LDH RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 469.01, REPEAT 284.91, 296.18, 294.58 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9106572 ↗MalfunctionSep 20, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). INITIAL 1932, REPEATS 209, 219 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9099379 ↗MalfunctionJul 22, 2019High Test Results; High Test Results
THE ACCOUNT GENERATED FALSELY ELEVATED ARCHITECT LDH OF 504 U/L THAT REPEATED 154 AND 156 U/L WITH SID (B)(6). NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8814559 ↗MalfunctionJul 19, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED IMPRECISION ON THE ARCHITECT C16000 SYSTEM. SID (B)(6): LDH RESULT OF 267 U/L RETESTED AT 132. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8808523 ↗MalfunctionJul 15, 2019High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ARCHITECT ANALYZER FOR MULTIPLE HEALTH FAIR PATIENTS. 163 PATIENT SAMPLES WERE PROCESSED, SIDS SEQUENTIALLY STARTING AT (B)(6). PER THE CUSTOMER, 90% OF PATIENT RESULTS WERE GREATER THAN 220 U/L; 60% OF PATIENT RESULTS WERE GREATER THAN 241 U/L (NORMAL RANGE: 125-220 U/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8789885 ↗MalfunctionJun 26, 2019High Test Results; High Test Results
THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT LACTATE DEHYDROGENASE (LDH) RESULT WERE GENERATED FOR PATIENT SAMPLES. THE CUSTOMER'S NORMAL RANGE IS 125 - 220 U/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE FOLLOWING DATA WAS PROVIDED. SAMPLE ID (B)(6): INITIAL 360, REPEAT 181 U/L; SAMPLE ID (B)(6): INITIAL 297, REPEAT 220 U/L; SAMPLE ID (B)(6): INITIAL 384, REPEAT 238 U/L; SAMPLE ID (B)(6): INITIAL 282, REPEAT 221 U/L.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8735081 ↗MalfunctionMay 13, 2019High Test Results; High Test Results
THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT LACTATE DEHYDROGENASE RESULTS FOR ONE SAMPLE. THE SAMPLE (ID 426 AND 1426) GENERATED AN INITIAL RESULT OF 933 U/ML, AND RETESTS OF 623 AND 206 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8604963 ↗MalfunctionApr 3, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED A FALSELY ELEVATED LACTATE DEHYGROGENASE (LDH) RESULT WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER INDICATED THE PATIENT WAS ADMITTED AFTER THE INITIAL RESULT WAS GENERATED. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL 1154, RETEST RESULTS: 214, 209 AND 215 U/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8478584 ↗MalfunctionApr 1, 2019High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL PLASMA SAMPLE = 418U/L / REPEAT = 236U/L; SID (B)(6) SERUM SAMPLE = 264 / 270U/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8471262 ↗MalfunctionMar 22, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS FOR CHEMOTHERAPY PATIENT THAT IS PARTAKING IN A CLINICAL TRIAL. ADDITIONAL PATIENT RESULTS ARE IN QUESTION BUT NO ADDITIONAL RESULT DATA WAS PROVIDED. ON (B)(6) 2016 (PLASMA): INITIAL 431U/L, RETEST 298U/L, 196U/L. THE CUSTOMER IS CONCERNED THAT IF THE RESULTS STAY HIGH THE PATIENT MAY NEED TO END THEIR PARTICIPATION IN THE STUDY. HOWEVER, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8446089 ↗MalfunctionMar 22, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYGROGENASE (LDH) RESULTS WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: PATIENT 1: (NO SID PROVIDED) INITIAL 121, RETEST 93 SID: (B)(6), INITIAL 641, RETEST 279 AND 315, SID: (B)(6), INITIAL 1286, RETEST 279 AND 219, SID: (B)(6), INITIAL 636, RETEST 251 AND 251. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8446018 ↗MalfunctionMar 21, 2019High Test Results; High Test Results
THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT LDH RESULTS ON ID (B)(6) OF 558, 184 AND 256 U/L. THE ACCOUNT USES A NORMAL LDH RANGE OF 125 TO 220 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8442431 ↗MalfunctionMar 12, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED A FALSELY ELEVATED LACTATE DEHYGROGENASE (LDH) RESULT WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER INDICATED THE PATIENT WAS ADMITTED AFTER THE INITIAL RESULT WAS GENERATED. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL 1154, RETEST RESULTS: 214, 209 AND 215 U/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8411818 ↗MalfunctionJan 30, 2019High Test Results; High Test Results
THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT LDH RESULTS FOR A PATIENT. SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 997.5 U/L AND RETEST RESULTS OF 168.5 U/L AND 161 U/L. THE SAME SAMPLE WAS RAN ON TWO OTHER ANALYZERS AND GENERATED RESULTS OF 167 AND 163 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8290951 ↗MalfunctionJan 24, 2019High Test Results; High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT LACTATE DEHYDROGENASE RESULTS ON THE ALINITY C ANALYZER. SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 657 AND WHEN REPEATED 193 UI/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8274021 ↗MalfunctionJan 18, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS FOR 2 PATIENTS (REFERENCE RANGE 125 TO 220 U/L): PATIENT 1: INITIAL 303, RETESTS: 238, 218, 300 AND 295 U/L; PATIENT 2: INITIAL 349, RETESTS: 214, 205 AND 206. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8261501 ↗
Other NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE devices
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- Lactate Dehydrogenase acc. to IFCC ver.2 08057958190Roche Diagnostics GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE15 reports
- ARCHITECT 2P56-22Abbott GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE13 reports
- Lactate Dehydrogenase acc to IFCC ver2 3004732122Roche Diagnostics GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE8 reports
- Alinity 07P7420Abbott GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE6 reports
- ARCHITECT 2P56-42Abbott GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE3 reports
- Lactate Dehydrogenase acc. to IFCC ver.2 5401674190Roche Diagnostics GmbH · NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.