Dimension® Flex® reagent cartridge AMY 10444965Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Amylase Flex® reagent cartridge, 240 tests · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768005404), received between Apr 12, 2018 and Apr 12, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (2 reports).
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 Results2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2018High Test Results; High Test Results
A DISCORDANT, FALSELY ELEVATED AMYLASE (AMY) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION RXL MAX HM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. ADDITIONAL SAMPLES WERE COLLECTED AND RUN ON THE SAME PATIENT LATER IN THE DAY AND LOWER RESULTS WERE OBTAINED. THE PATIENT WAS HOSPITALIZED FOR SUSPECTED PANCREATITIS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED AMY RESULT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7427109 ↗MalfunctionApr 12, 2018High Test Results; High Test Results
A DISCORDANT, FALSELY ELEVATED AMYLASE (AMY) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION RXL MAX HM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS TESTED ON THE SAME INSTRUMENT AT A LATER DATE AND AN ELEVATED RESULT WAS OBTAINED. THE PATIENT WAS HOSPITALIZED FOR SUSPECTED PANCREATITIS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED AMY RESULT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7427108 ↗
Other CATALYTIC METHODS, AMYLASE devices
- P AMY AY3855Randox Laboratories Limited · Catalytic Methods, Amylase1 recall0 reports
- Amylase EPS ver2 3183742122Roche Diagnostics GmbH · CATALYTIC METHODS, AMYLASE4 reports
- a-Amylase EPS ver.2 08056811190Roche Diagnostics GmbH · CATALYTIC METHODS, AMYLASE1 report
- ARCHITECT 7D58-22Abbott GmbH · CATALYTIC METHODS, AMYLASE1 report
- alpha-Amylase EPS ver.2 5167027190Roche Diagnostics GmbH · CATALYTIC METHODS, AMYLASE1 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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