P AMY AY3855Recalls & reported problems
Randox Laboratories Limited · A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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 16, 2026.
Recalls naming this device
- Jul 10, 2020Terminated
Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.
Z-2924-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Catalytic Methods, Amylase devices
- Amylase EPS ver2 3183742122Roche Diagnostics GmbH · CATALYTIC METHODS, AMYLASE4 reports
- Dimension® Flex® reagent cartridge AMY 10444965Siemens Healthcare Diagnostics Inc. · CATALYTIC METHODS, AMYLASE2 reports
- a-Amylase EPS ver.2 08056811190Roche Diagnostics GmbH · CATALYTIC METHODS, AMYLASE1 report
- alpha-Amylase EPS ver.2 5167027190Roche Diagnostics GmbH · CATALYTIC METHODS, AMYLASE1 report
- ARCHITECT 7D58-22Abbott 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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