Axis-Shield Active-B12 (Holotranscobalamin) EIA FMABT100Recalls & reported problems
Axis-Shield Diagnostics Limited · The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency. · Class 2
Data updated Oct 18, 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 05055845400046), received between Jul 17, 2024 and Jul 17, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Measurement” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement1
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.
MalfunctionJul 17, 2024Incorrect Measurement; Incorrect Measurement
AXIS-SHIELD DIAGNOSTICS LTD. RECEIVED NOTIFICATION OF A COMPLAINT ON (B)(6) 2024 STATING THE CUSTOMER HAD EXPERIENCED OUT OF RANGE RESULTS, RELATING TO THE HIGH AND LOW CONTROLS REPORTING RESULTS OUT OF RANGE, WHEN USING FMABT100 LOT 902959842. THERE WAS NO IMPACT TO PATIENT. THE CUSTOMER HAD AN ADDITIONAL LOT THAT DID NOT DISPLAY THE SAME ERROR AND WAS ABLE TO PROCEED WITH TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19760113 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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