ARCHITECT 7D63-21Recalls & reported problems
Abbott Laboratories · Creatine Kinase · Class 2
Quick summary
This Abbott ARCHITECT creatine kinase test has 1,435 FDA adverse event reports, with no deaths and no injuries. The reports mostly describe the analyzer being unable to produce results, with some describing low test results, and most reports say patient care was not affected. One closed recall names this device; it began in July 2018 over a product stability problem that can cause error codes and low control results.
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
- 1,435
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,435 adverse event reports that list this exact device (DI 00380740012878), received between Jul 20, 2018 and Dec 10, 2019 — classified as 1,435 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (1,357 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Jul 18, 2018Terminated
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
Z-1075-2019 · Root cause: Material/Component Contamination · FDA record ↗
Most reported problems
Device problems
- Unable to Obtain Readings1,357
- Low Test Results185
Patient problems
- No Patient Involvement967
- No Known Impact Or Consequence To Patient468
Recent adverse event reports
The 25 most recent of 1,435 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2019Low Test Results; Low Test Results
THE CUSTOMER REPORTED FALSELY DEPRESSED CREATINE KINASE (CK) ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: AUTO DILUTION 1:10 = 477.4IU/L / MANUAL DILUTION 1:10 =32619.1IU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9446774 ↗MalfunctionJan 25, 2019Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR CONTROLS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8279021 ↗MalfunctionJan 25, 2019Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER REPORTED THEY RECEIVED THE LETTER ASSOCIATED WITH QC SHIFTING LOW AND ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE FOR THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). NO FURTHER INFORMATION COULD BE OBTAINED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8279002 ↗MalfunctionJan 25, 2019Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER (B)(4), LOT NUMBER 99632UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8278963 ↗MalfunctionDec 26, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR PATIENT RESULTS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 99632UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8196658 ↗MalfunctionDec 26, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR PATIENT RESULTS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 99632UN18). THE CUSTOMER INDICATED THE ERROR OCCURRED WITH SAMPLE ID (B)(6). NO FURTHER PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8196563 ↗MalfunctionDec 26, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR CONTROLS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 24358UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8196429 ↗MalfunctionNov 30, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE: 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR PATIENT RESULTS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 99632UN18 AND 24358UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8121337 ↗MalfunctionNov 30, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR PATIENT RESULTS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 99632UN18 AND 24358UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8121329 ↗MalfunctionNov 30, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR PATIENT SAMPLES AND WHILE PERFORMING THE CALIBRATION OF ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 24358UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8121149 ↗MalfunctionNov 30, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR BIORAD CONTROLS AND PATIENT RESULTS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 24358UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8120686 ↗MalfunctionNov 28, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8111481 ↗MalfunctionOct 24, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR TECHNOPATH CONTROLS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 99632UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8000636 ↗MalfunctionOct 24, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR CONTROLS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8000559 ↗MalfunctionOct 24, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE FOR PATIENT RESULTS WHILE USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 24358UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8000395 ↗MalfunctionOct 24, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR CONTROLS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 24358UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8000326 ↗MalfunctionOct 24, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR PATIENT RESULTS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 99632UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8000224 ↗MalfunctionOct 24, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR CONTROLS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 7999973 ↗MalfunctionOct 21, 2018Low Test Results; Low Test Results
THE CUSTOMER OBSERVED TECHNOPATH QC SHIFTING LOW OUT OF RANGE, WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7988414 ↗MalfunctionOct 21, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR CONTROLS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 7988413 ↗MalfunctionOct 21, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR TECHNOPATH LOW CONTROL AND PATIENT RESULTS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7988407 ↗MalfunctionOct 21, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR PATIENT RESULTS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 99632UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7988405 ↗MalfunctionOct 21, 2018Low Test Results; Low Test Results
THE CUSTOMER OBSERVED BIORAD QC SHIFTING LOW OUT OF RANGE, WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7988404 ↗MalfunctionOct 21, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR CONTROLS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 99632UN18). THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 7988402 ↗MalfunctionOct 18, 2018Unable to Obtain Readings; Unable to Obtain Readings
THE CUSTOMER OBSERVED ERROR CODE 1054 UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE, FOR PATIENT RESULTS WHEN USING THE ARCHITECT CREATINE KINASE ASSAY (LIST NUMBER 7D63, LOT NUMBER 87697UN18). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7981457 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.