Alinity 09P4120Recalls & reported problems
Abbott Ireland Diagnostics · Alinity i Sirolimus Reagent Kit 200 Tests · 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 00380740150990), received between Jun 3, 2022 and Jun 3, 2022 — 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 Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2022Low Test Results; Low Test Results
THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I SIROLIMUS RESULTS ON ONE PATIENT SPECIMEN. THE RESULTS PROVIDED WERE: ON (B)(6) 2022. SID (B)(6) =2.98 NG/L /REPEATED=8.05 NG/L /REPEATED FEW TIMES=8.0, 8.1 AND 8.7 NG/L WHICH MATCHED WITH PATIENT¿S PREVIOUS HISTORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14591872 ↗
Other Sirolimus test system devices
- Dimension® Flex® reagent cartridge SIRO 10464331Siemens Healthcare Diagnostics Inc. · Sirolimus test system3 reports
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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