Amylase EPS ver2 3183742122Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630918935), received between Apr 18, 2022 and Jan 22, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLES NOT MATCHING THE PATIENT'S CLINICAL DIAGNOSIS WHEN TESTED WITH AMYL GEN.2 (AMYL2) ASSAY AND LIPASE COLORIMETRIC ASSAY (LIPC) ASSAY ON A COBAS 8000 COBAS C502 MODULE. THIS MEDWATCH WILL APPLY TO THE LIPC ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE AMYL2 ASSAY. ON (B)(6) 2024, THE 1ST SAMPLE (SERUM/PLASMA SAMPLE) WAS TESTED RESULTING IN: AMYL2 RESULT: 576 U/L. LIPC RESULT: 1692.5 U/L. ON (B)(6) 2024, THE PHYSICIAN REQUESTED A 2ND SAMPLE TO BE DRAWN AND TESTED RESULTING IN: AMYL2 RESULT: 338 U/L (URINE SAMPLE). AMYL2 RESULT: 104 U/L (SERUM SAMPLE). LIPC RESULT: 47.8 U/L (SERUM SAMPLE). ON (B)(6) 2024, THE PHYSICIANS QUESTIONED THE RESULTS AND REQUESTED A 3RD BLOOD SAMPLE TO BE DRAWN AND TESTED RESULTING IN: AMYL2 RESULT: 195 U/L. LIPC RESULT: 259.3 U/L. ON (B)(6) 2024, THE ORIGINAL SAMPLE WAS REPEATED RESULTING IN: AMYL2 RESULT: 577 U/L. LIPC RESULT: 1644.4 U/L. THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND EXPECTATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209354 ↗
• MalfunctionJan 22, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLES NOT MATCHING THE PATIENT'S CLINICAL DIAGNOSIS WHEN TESTED WITH AMYL GEN.2 (AMYL2) ASSAY AND LIPASE COLORIMETRIC ASSAY (LIPC) ASSAY ON A COBAS 8000 COBAS C502 MODULE. THIS MEDWATCH WILL APPLY TO THE AMYL2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE LIPC ASSAY. ON (B)(6) 2024, THE 1ST SAMPLE (SERUM/PLASMA SAMPLE) WAS TESTED RESULTING IN: AMYL2 RESULT: 576 U/L. LIPC RESULT: 1692.5 U/L. ON (B)(6) 2024, THE PHYSICIAN REQUESTED A 2ND SAMPLE TO BE DRAWN AND TESTED RESULTING IN: AMYL2 RESULT: 338 U/L (URINE SAMPLE). AMYL2 RESULT: 104 U/L (SERUM SAMPLE). LIPC RESULT: 47.8 U/L (SERUM SAMPLE). ON (B)(6) 2024, THE PHYSICIANS QUESTIONED THE RESULTS AND REQUESTED A 3RD BLOOD SAMPLE TO BE DRAWN AND TESTED RESULTING IN: AMYL2 RESULT: 195 U/L. LIPC RESULT: 259.3 U/L. ON (B)(6) 2024, THE ORIGINAL SAMPLE WAS REPEATED RESULTING IN: AMYL2 RESULT: 577 U/L. LIPC RESULT: 1644.4 U/L. THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND EXPECTATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209351 ↗
• MalfunctionMay 30, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH AMYLASE (AMYL2) ON A COBAS 6000 C 501 MODULE (B)(6). THE RESULTS DID NOT AGREE WITH THE CLINICAL STATUS OF THE PATIENT. THE SAMPLE INITIALLY RESULTED IN AN AMYLASE VALUE OF 133 U/L AND REPEATED AS 135 U/L. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PATIENT'S DOCTOR. A SECOND SAMPLE WAS ALSO COLLECTED FROM THE PATIENT ON (B)(6) 2023 AND TESTED, RESULTING IN AN AMYLASE VALUE OF 146 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021815 ↗
• MalfunctionApr 18, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH AMYLASE (AMYL2) ON A COBAS 8000 C 502 MODULE (SERIAL NUMBER UNKNOWN) AND A COBAS 6000 C (501) MODULE (SERIAL NUMBER (B)(4)). THE RESULTS DID NOT AGREE WITH THE CLINICAL STATUS OF THE PATIENT. THE SAMPLE INITIALLY RESULTED IN AN AMYLASE VALUE OF 460 U/L ON THE C 502 ANALYZER. SINCE THE LABORATORY HAD NO HISTORICAL DATA FROM THIS PATIENT, THE INITIAL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE PATIENT'S DOCTOR ASKED THE LABORATORY TO REPEAT THE SAMPLE SINCE THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL STATUS. ACCORDING TO THE PATIENT'S DOCTOR, THE PATIENT HAD NO PATHOLOGIES. THE COMPLAINED SAMPLE WAS THEN REPEATED ON THE C 501 ANALYZER (B)(6) 2022. RESULTING IN AN AMYLASE VALUE OF 468 U/L. A SECOND SAMPLE WAS ALSO COLLECTED FROM THE PATIENT AND TESTED (B)(6) 2022. RESULTING IN AN AMYLASE VALUE OF 53 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137519 ↗

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 · Terminated
  Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250