Alinity 08P4532Recalls & reported problems
Abbott Ireland · Alinity i 25-OH Vitamin D Reagent Kit 1000 Tests · Class 2
All models of Alinity (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740121952), received between Nov 21, 2018 and May 11, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-0669-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Damaged Prior to Use2
- Unable to Obtain Readings2
- Low Test Results1
Patient problems
- No Patient Involvement2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2021Low Test Results; Low Test Results
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER INDICATING THAT THE PATIENT IS 69 YEARS OLD WITH A HISTORY OF CARDIOMYOPATHY STATUS POST PACEMAKER PLACEMENT, CEREBROVASCULAR INCIDENT, WARFARIN THERAPY, OSTEOPOROSIS, AND VITAMIN D DEFICIENCY. THE OUTCOME OF THE ENDOSCOPY WAS THAT THE PATIENT HAD A VERY BENIGN UPPER ENDOSCOPY. NO CAUSE FOR HIS VITAMIN D DEFICIENCY OR GI SYMPTOMS WAS OBSERVED.
Patient problems: Insufficient Information
MAUDE report 11807443 ↗MalfunctionFeb 5, 2019Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use
THE CUSTOMER REQUESTED REPLACEMENT OF 13 PACKS OF ALINITY I 25-OH VITAMIN D REAGENT PER THE PRODUCT RECALL LETTER REGARDING A MANUFACTURING ISSUE THAT MAY RESULT IN DAMAGE TO A BOTTLE NECK IN SOME REAGENT CARTRIDGES. THERE WAS NO REPORT OF ANY PATIENT IMPACT DUE TO THE POTENTIAL DELAY IN GENERATING 25-OH VITAMIN D RESULTS RELATED TO THIS ISSUE.
Patient problems: No Patient Involvement
MAUDE report 8305495 ↗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 8097240 ↗
Other SYSTEM, TEST, VITAMIN D devices
- Elecsys Vitamin D total III 09038086190Roche Diagnostics GmbH · SYSTEM, TEST, VITAMIN D42 reports
- Elecsys Vitamin D total II 07028148190Roche Diagnostics GmbH · SYSTEM, TEST, VITAMIN D11 reports
- Elecsys Vitamin D total III 09038078160Roche Diagnostics GmbH · SYSTEM, TEST, VITAMIN D8 reports
- Elecsys Vitamin D total II 07464215160Roche Diagnostics GmbH · SYSTEM, TEST, VITAMIN D3 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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