Alinity 07P6530Recalls & reported problems
Abbott Ireland · Alinity i Ferritin Reagent Kit 1200 Tests · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380740131487), received between Nov 21, 2018 and Apr 25, 2019 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (7 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
- Nov 21, 2018Terminated
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Z-2208-2019 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Device Damaged Prior to Use7
- Unable to Obtain Readings7
Patient problems
- No Patient Involvement6
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2019Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use
THE CUSTOMER OBSERVED ERROR CODES 5652, 5662 AND 5819 RELATED TO REAGENT CARTRIDGE LOADING WHILE ATTEMPTING TO LOAD ALINITY I FERRITIN REAGENT LOT 91532UI00 ON THE ALINITY I PROCESSING MODULE. THERE WAS NO REPORT OF ANY PATIENT IMPACT DUE TO THE POTENTIAL DELAY IN GENERATING FERRITIN RESULTS.
Patient problems: No Patient Involvement
MAUDE report 8550231 ↗MalfunctionDec 20, 2018Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use
THE CUSTOMER OBSERVED ERROR CODE 5662 (REAGENT TRANSPORT FAILED TO LOAD REAGENT CARTRIDGE OR RACK IN REAGENT CAROUSEL) WHILE LOADING ALINITY I FERRITIN REAGENT LOT 91532UI00 ON THE ALINITY I PROCESSING MODULE. THERE WAS NO REPORT OF ANY PATIENT IMPACT DUE TO THE POTENTIAL DELAY IN GENERATING FERRITIN RESULTS.
Patient problems: No Patient Involvement
MAUDE report 8187145 ↗MalfunctionDec 20, 2018Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use
THE CUSTOMER OBSERVED ERROR CODE 5817 (UNABLE TO INITIALIZE MODULE DUE TO PREVIOUS LOAD OR UNLOAD ERROR. REMOVE REAGENT CARTRIDGE OR RACK WITH LOAD OR UNLOAD ERROR FROM REAGENT CAROUSEL) WHILE LOADING ALINITY I FERRITIN REAGENT LOT 93238UI00 ON THE ALINITY I PROCESSING MODULE. THERE WAS NO REPORT OF ANY PATIENT IMPACT DUE TO THE POTENTIAL DELAY IN GENERATING FERRITIN RESULTS.
Patient problems: No Patient Involvement
MAUDE report 8186942 ↗MalfunctionDec 20, 2018Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use
THE CUSTOMER WAS UNABLE TO TURN THE MICROPARTICLE PORTION OF THE ALINITY I FERRITIN REAGENT CARTRIDGE LOT 93238UI00 ON THE ALINITY I PROCESSING MODULE. THERE WAS NO REPORT OF ANY PATIENT IMPACT DUE TO THE POTENTIAL DELAY IN GENERATING FERRITIN RESULTS.
Patient problems: No Patient Involvement
MAUDE report 8186381 ↗MalfunctionDec 20, 2018Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use
THE CUSTOMER OBSERVED LOAD FAILURE ERROR CODES 5819, 5818, 5672 AND 5794 WHEN ATTEMPTING TO LOAD ALINITY I FERRITIN REAGENT CARTRIDGE LOT 91532UI00 ON THE ALINITY I PROCESSING MODULE. THERE WAS NO REPORT OF ANY PATIENT IMPACT DUE TO THE POTENTIAL DELAY IN GENERATING FERRITIN RESULTS.
Patient problems: No Patient Involvement
MAUDE report 8186096 ↗MalfunctionDec 14, 2018Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use
THE CUSTOMER OBSERVED ERROR CODES 5818 (REAGENT TRANSPORT ERROR), 5819 (REAGENT CARTRIDGE LOAD ERROR AT REAGENT CAROUSEL POSITION 27) AND 5794 (REAGENT CAROUSEL LOAD ERROR) WHILE LOADING ALINITY I FERRITIN REAGENT LOT: 91532UI00 ON THE ALINITY I PROCESSING MODULE. THERE WAS NO REPORT OF ANY PATIENT IMPACT DUE TO THE POTENTIAL DELAY IN GENERATING FERRITIN RESULTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8165574 ↗MalfunctionNov 21, 2018Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use
ABBOTT LABORATORIES HAS BECOME AWARE OF A MANUFACTURING ISSUE THAT CAN RESULT IN DAMAGE TO A BOTTLE NECK IN SOME REAGENT CARTRIDGES. IF A BOTTLE NECK IS DAMAGED, IT MAY CAUSE A FAILURE DURING THE REAGENT LOADING PROCESS ON THE ALINITY I INSTRUMENT. WHEN THE FAILURE OCCURS, ERROR CODES WILL BE GENERATED WHICH MAY LEAD TO THE POTENTIAL OF DELAYED PATIENT RESULTS. NO PATIENT INJURY HAS BEEN REPORTED DUE TO THIS ISSUE.
Patient problems: No Patient Involvement
MAUDE report 8097185 ↗
Other FERRITIN, ANTIGEN, ANTISERUM, CONTROL devices
- Tinaquant Ferritin Gen4 4885317190Roche Diagnostics GmbH · FERRITIN, ANTIGEN, ANTISERUM, CONTROL3 reports
- Tinaquant Ferritin Gen4 5172390190Roche Diagnostics GmbH · FERRITIN, ANTIGEN, ANTISERUM, CONTROL2 reports
- Tina-quant Ferritin Gen.4 08057648190Roche Diagnostics GmbH · FERRITIN, ANTIGEN, ANTISERUM, CONTROL2 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 · each recall links to the FDA recall notice
- 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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