ADVIA® 360/560 Dil (20L) 11170845Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · ADVIA® 360/560 Dil 20L · 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 00630414601274), received between Oct 4, 2019 and Oct 4, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K111534); 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
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2019Use of Device Problem; Use of Device Problem
THE CUSTOMER RECEIVED CONTAINERS OF ADVIA 360/560 DILUENT THAT WERE DAMAGED DURING TRANSPORTATION. THE CUSTOMER WAS EXPOSED TO THE DILUENT SOLUTION ON THEIR ARMS AND WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT. THE CUSTOMER WAS NOT INJURED DUE TO EXPOSURE TO THE DILUENT AND DID NOT SEEK MEDICAL ATTENTION. THE DAMAGED CONTAINERS OF DILUENT WERE DISCARDED. THERE ARE NO REPORTS OF MEDICAL INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER'S SKIN BEING EXPOSED TO THE ADVIA 360/560 DILUENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9158095 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K111534. One submission often covers many models, so check the product and lot details in each record.
- Z-0723-2017 · Oct 21, 2016 · TerminatedADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
- Z-1500-2016 · Mar 10, 2016 · TerminatedADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnos
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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