Homocysteine Enzymatic Assay 08057826190Recalls & reported problems

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 07613336121290), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K113793); 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Difficult to Setup or Prepare1
Low Test Results1
Non Reproducible 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.

MalfunctionAug 7, 2024Device Difficult to Setup or Prepare; Low Test Results; Non Reproducible Results; Device Difficult to Setup or Prepare; Low Test Results; Non Reproducible Results
THERE WAS AN ALLEGATION OF QUESTIONABLE LOW RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR HOMOCYSTEINE ENZYMATIC ASSAY (HCYS) ON A COBAS PURE ANALYZER COMPARED TO A HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD. OF THE DATA PROVIDED FOR 11 PATIENT SAMPLES, THE RESULTS FOR 10 PATIENT SAMPLES WERE DISCREPANT. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19930753 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113793. One submission often covers many models, so check the product and lot details in each record.

Z-0489-2025 · Oct 17, 2024 · Open, Classified
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Z-0679-2020 · Oct 4, 2019 · Terminated
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190
Z-1622-2015 · Mar 23, 2015 · Terminated
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative

Device details

UDI-DI	`07613336121290`
Brand	Homocysteine Enzymatic Assay
Model	08057826190
Company	Roche Diagnostics GmbH
Product code	LPS · URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM
Class	Class 2
FDA submission	K113793
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2023

Device type (GMDN): Homocysteine IVD, kit, spectrophotometry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of homocysteine in a clinical specimen, using a spectrophotometry method.

Other URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM devices

Homocysteine Enzymatic Assay 6542921190
Roche Diagnostics GmbH · URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM
1 recall0 reports

All URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.