Dimension Vista® Flex® reagent cartridge AMM 10711992Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Ammonia Flex® reagent cartridge, 120 tests · Class 1
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 00630414948102), received between Mar 18, 2021 and Mar 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
1 other recall cover devices cleared under the same FDA submission (K123677); 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
- 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.
MalfunctionMar 18, 2021High Test Results; High Test Results
A DISCORDANT, FALSELY ELEVATED AMMONIA (AMM) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FACILITY AND A NEW SAMPLE WAS PROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT. A LOWER RESULT WAS OBTAINED AND REPORTED. THE CUSTOMER STATED THAT THE PATIENT WAS SENT TO THE ALTERNATE HOSPITAL DUE TO THE DISCORDANT, FALSELY ELEVATED AMM RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT AMM RESULT OR DUE TO THE TRANSFER TO THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11519038 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123677. One submission often covers many models, so check the product and lot details in each record.
- Z-1655-2018 · Jun 29, 2017 · TerminatedDimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Other ENZYMATIC METHOD, AMMONIA devices
- AMMONIA (NH3) AM1054Randox Laboratories Limited · Enzymatic Method, Ammonia1 recall0 reports
- Ammonia II 07229593190Roche Diagnostics GmbH · ENZYMATIC METHOD, AMMONIA6 reports
- Ammonia II 07236450190Roche Diagnostics GmbH · ENZYMATIC METHOD, AMMONIA5 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.
How reports and recalls are matched · Editorial policy · Report an error on this page