ARCHITECT 1L82-25Recalls & reported problems
Abbott Ireland Diagnostics · ARCHITECT AUSAB Reagent Kit · 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 00380740001513), received between Oct 25, 2017 and Oct 25, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Or Inadequate 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
- Incorrect Or Inadequate 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 25, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results
THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING THE ARCHITECT AUSAB REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR ONE PATIENT (MIU/ML). (B)(6). PER THE PRODUCT PACKAGE INSERT, WHEN INITIAL RESULT IS LESS THAN OR EQUAL TO 8.00 TO LESS THAN 12.00 MIU/ML THE INTERPRETATION IS GRAYZONE AND INSTRUCTS THE USER TO RETEST IN DUPLICATE. NONREACTIVE RESULTS (LESS THAN 8.00 MIU/ML) AND REACTIVE RESULTS (GREATER THAN OR EQUAL TO 12.00 MIU/ML) DO NOT REQUIRE RETEST. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6977588 ↗
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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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