Accutrend Plus Cholesterol strips 05213312160Recalls & reported problems
Roche Diagnostics GmbH · Class 1
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 00365702276109), received between Jun 28, 2022 and Jun 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
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 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.
MalfunctionJun 28, 2022High Test Results; High Test Results
THERE WAS AN ALLEGATION OF QUESTIONABLE CHOLESTEROL RESULTS FROM MULTIPLE ACCUTREND PLUS METERS. THE CUSTOMER USED METER SERIAL NUMBERS (B)(4). THE CUSTOMER NOTICED THEY WERE GETTING MORE HI (>300 MG/DL) RESULTS WITH THEIR ACCUTREND METERS THAN NORMAL. THE CUSTOMER PERFORMED A COMPARISON AGAINST CARDIOCHEK METERS THAT PROVIDES A BREAKDOWN OF THE DIFFERENT CHOLESTEROL RESULTS AND THEY GOT A HI ON THAT BRAND. WHEN THEY BROKE THE RESULT DOWN, THE TOTAL CHOLESTEROL RESULT WAS 198 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14842770 ↗
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
- Alere Cholestech LDX® 10-987Alere San Diego, Inc. · Enzymatic Esterase--Oxidase, Cholesterol1 recall0 reports
- Synchron 467825Beckman Coulter, 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
- Cholesterol Gen.2 04718917190Roche Diagnostics GmbH · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL2 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page