ARCHITECT 1P35-25Recalls & reported problems
Abbott Laboratories · ARCHITECT iValproic Acid Reagent Kit · Class 2
All models of ARCHITECT (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740001827), received between Oct 3, 2019 and Oct 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2019Low Test Results; Low Test Results
THE CUSTOMER REPORTED FALSE DECREASED IVALPROIC ACID RESULTS WHEN PROCESSING ON THE ARCHITECT I2000SR. THE INITIAL RESULT FOR (B)(6) WAS GREATER THAN 150 (209.639 UG/ML). RETEST AFTER DILUTION WAS 77.40 UG/ML. RETEST RESULT OF THE DILUTED SAMPLE WAS 78.29 UG/ML. THE SAMPLE WAS TESTED UNDILUTED AND THE RESULT WAS GREATER THAN 150 AND THIS SAMPLE WAS DILUTED AND GENERATED A RESULT OF 40.98 UG/ML. ADDITIONAL TESTING USING GASCHROMATOGRAPHY GENERATED A RESULT OF 75. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9150292 ↗
Other CALIBRATORS, DRUG SPECIFIC devices
- VITROS 6801696Ortho-Clinical Diagnostics, Inc. · CALIBRATORS, DRUG SPECIFIC1 recall1 report
- ARCHITECT 1L75-25Abbott Laboratories · CALIBRATORS, DRUG SPECIFIC17 reports
- VITROS 6801697Ortho-Clinical Diagnostics, Inc. · CALIBRATORS, DRUG SPECIFIC3 reports
- ARCHITECT 1L75-55Abbott Laboratories · CALIBRATORS, DRUG SPECIFIC1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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