alpha-Amylase EPS ver.2 5167027190Recalls & reported problems
Roche Diagnostics GmbH · 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 04015630924875), received between Mar 23, 2026 and Mar 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (1 report).
1 other recall cover devices cleared under the same FDA submission (K972250); 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.
Reports received per month
Most reported problems
Device problems
- Low 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 23, 2026Low Test Results
THERE WAS AN ALLEGATION OF QUESTIONABLE AMYLASE EPS VER.2 ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON A COBAS 8000 CORE UNIT. THE INITIAL RESULT WAS -1 U/L (ACCOMPANIED BY A DATA FLAG). THE REPEAT RESULT WAS 199 U/L WITH A 5-FOLD DILUTION. THE SAMPLE WAS REPEATED NEAT AND THE RESULT WAS 0 (ACCOMPANIED BY A DATA FLAG), AND WITH A 1:5 DILUTION, THE RESULT WAS 198 U/L. NO ERRONEOUS RESULT WAS RELEASED OUTSIDE OF THE LABORATORY. AN INTERFERENCE IS SUSPECTED IN THE SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660351 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K972250. One submission often covers many models, so check the product and lot details in each record.
- Z-0688-2008 · Dec 3, 2007 · TerminatedRoche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
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
- 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
- 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 · 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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