ARCHITECT 9D96-21Recalls & reported problems
Abbott Laboratories · CLIN CHEM C3 REAGENT · Class 2
Data updated Oct 13, 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 00380740019730), received between Jun 5, 2019 and Jun 5, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2019Low Test Results; Low Test Results
ABBOTT IDENTIFIED THAT AN UPDATE TO THE REAGENT AND SPECIMEN COLLECTION AND HANDLING/PREPARATION FOR ANALYSIS SECTIONS OF THE INSTRUCTIONS FOR USE (IFU) FOR THE INCLUDED ARCHITECT PRODUCTS WAS REQUIRED FOR THE FOLLOWING ISSUES: BASED ON RECENT FIBRINOGEN INTERFERENCE TESTING, IT HAS BEEN DETERMINED THAT EDTA PLASMA SAMPLES ARE NO LONGER ACCEPTABLE FOR USE WITH THE FOLLOWING ASSAYS: APOLIPOPROTEIN A1 (APO A1), COMPLEMENT C3 (C3), COMPLEMENT C4 (C4), HAPTOGLOBIN, IMMUNOGLOBULIN G (IGG), IMMUNOGLOBULIN A (IGA), AND IMMUNOGLOBULIN M (IGM). THERE IS A POTENTIAL FOR FALSELY DEPRESSED RESULTS DUE TO FIBRINOGEN INTERFERENCE WITH EDTA SPECIMENS FOR THESE PRODUCTS. ADDITIONALLY, FOR THE COMPLEMENT C4 ASSAY, THERE IS A POTENTIAL FOR FALSELY DEPRESSED RESULTS DUE TO FIBRINOGEN INTERFERENCE WITH HEPARIN TUBES AT THE CONCENTRATIONS > 1512 MG/DL IN LITHIUM HEPARIN TUBES AND >859 MG/DL IN SODIUM HEPARIN TUBES. ADDITIONALLY, BASED ON RECENT TESTING, THE SPECIMEN STORAGE INFORMATION IS BEING REVISED FOR THE FOLLOWING ASSAYS: IGG, IGA, IGM, AND C3. THE MAXIMUM STORAGE TIME FOR SAMPLES STORED AT 2-8 DEGREES C AND 20-25 DEGREES C WERE INACCURATELY STATED. THESE ISSUES WERE IDENTIFIED THROUGH INTERNAL T
Patient problems: No Patient Involvement
MAUDE report 8671652 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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