Alinity 09P2635Recalls & reported problems
Abbott GmbH · Alinity i Active B-12 (Holotranscobalamin) Reagent Kit · Class 2
All models of Alinity (37)
Data updated Oct 16, 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 00380740189815), received between May 11, 2026 and May 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “High 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- High 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.
MalfunctionMay 11, 2026High Test Results
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I ACTIVE B12 RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. SID (B)(6) RESULT ON LOT 12569UP00 = 29.7 PMOL/L, RESULT ON OTHER LOT = 18.1 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136873 ↗
Other Radioassay, vitamin b12 devices
- Access Vitamin B12 33000Beckman Coulter, Inc. · Radioassay, Vitamin B121 recall16 reports
- ADVIA Centaur® CKMB MCM 10309782Siemens Healthcare Diagnostics Inc. · RADIOASSAY, VITAMIN B121 recall0 reports
- Atellica IM VB12 10995715Siemens Healthcare Diagnostics Inc. · RADIOASSAY, VITAMIN B1224 reports
- Elecsys Vitamin B12 II 07028121190Roche Diagnostics GmbH · RADIOASSAY, VITAMIN B1221 reports
- Atellica IM VB12 10995714Siemens Healthcare Diagnostics Inc. · RADIOASSAY, VITAMIN B1213 reports
- ADVIA Centaur® VB12 10309970Siemens Healthcare Diagnostics Inc. · RADIOASSAY, VITAMIN B128 reports
- ARCHITECT 7K61-37Abbott Ireland · RADIOASSAY, VITAMIN B124 reports
- ARCHITECT 7K61-27Abbott Ireland · RADIOASSAY, VITAMIN B123 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
- 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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