ADVIA® 120 Hematology System 10360958Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · ADVIA 120 Hematology System · 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 00630414574868), received between Nov 23, 2020 and Nov 23, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Smoking” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K971998); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Smoking1
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.
MalfunctionNov 23, 2020Smoking; Smoking
THE CUSTOMER OBSERVED SMOKE AND AN ELECTRICAL BURNING SMELL COMING FROM THE BACK OF THEIR ADVIA 120 HEMATOLOGY SYSTEM BY THE OUTLET PLUG AFTER HAVING SEVERAL POWER SURGES IN THEIR LAB. NO FLAMES WERE OBSERVED AND THERE ARE NO REPORTS OF DELAYS IN PATIENT TESTING. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10889378 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K971998. One submission often covers many models, so check the product and lot details in each record.
- Z-2114-2013 · Jun 26, 2013 · TerminatedADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide
- Z-1376-06 · Mar 16, 2006 · TerminatedADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
Other Counter, differential cell devices
- Cytomics FC500 UPS (CXP)Beckman Coulter, Inc. · Counter, Differential Cell1,196 reports
- CELL-DYN 08H67-01Abbott Laboratories · Counter, differential cell6 recalls269 reports
- Alinity 09P6801Abbott Laboratories · Counter, differential cell2 recalls96 reports
- FACSCanto 338960Becton, Dickinson And Company · Counter, differential cell1 recall117 reports
- Cytomics FC500 UPS (MPL)Beckman Coulter, Inc. · Counter, Differential Cell141 reports
- CELL-DYN 08H00-01Abbott Laboratories · Counter, differential cell1 recall90 reports
- CELL-DYN 09H39-01Abbott Laboratories · Counter, differential cell123 reports
- BD Multitest 662995Becton, Dickinson And Company · Counter, differential cell2 recalls1 report
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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