Cholesterol Gen.2 04718917190Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 16, 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 04015630922062), received between Jul 1, 2024 and Apr 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (1 report).
1 other recall cover devices cleared under the same FDA submission (K031824); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- High Test Results1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Non Reproducible Results
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 ON A COBAS C 111 ANALYZER. THE SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 408.19 MG/DL. THE SAMPLE WAS REPEATED, RESULTING IN CHOLESTEROL VALUES OF 203.71 MG/DL AND 201.57 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001605 ↗MalfunctionJul 1, 2024High Test Results; High Test Results
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 (CHOL2) ASSAY ON A COBAS C111 ANALYZER. INITIAL RESULT: 385 MG/DL. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND REQUESTED A REPEAT OF THE ORIGINAL SAMPLE. ON 10-JUN-2024: REPEAT RESULT: 213 MG/DL. THE REPEAT RESULT WAS CONSIDERED TO BE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19644150 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K031824. One submission often covers many models, so check the product and lot details in each record.
- Z-1921-2015 · May 7, 2015 · TerminatedCholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems,
Other ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL devices
- PTS Panels® CHOL+Glu Test Strips 1765Polymer Technology Systems, Inc. · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL2 recalls3 reports
- CardioChek 5700411Henry Schein, Inc. · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL1 recall5 reports
- Synchron 467825Beckman Coulter, Inc. · Enzymatic Esterase--Oxidase, Cholesterol1 recall0 reports
- Alere Cholestech LDX® 10-987Alere San Diego, Inc. · Enzymatic Esterase--Oxidase, Cholesterol1 recall0 reports
- Cholesterol 08057443190Roche Diagnostics GmbH · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL21 reports
- Cholesterol Gen.2 3039773190Roche Diagnostics GmbH · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL11 reports
- Cholesterol Gen.2 05168538190Roche Diagnostics GmbH · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL3 reports
- Dimension Vista® Flex® reagent cartridge CHOL 10445143Siemens Healthcare Diagnostics Inc. · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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