Homocysteine Enzymatic AssayRecalls & reported problems across all models

We found 2 models of Homocysteine Enzymatic Assay by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Homocysteine Enzymatic Assay recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 17, 2024Class IIOpen, Classified

   Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

   Z-0489-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Homocysteine Enzymatic Assay problems

Homocysteine Enzymatic Assay models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Homocysteine Enzymatic Assay 6542921190

  URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM
  1 recall0 reports
• Homocysteine Enzymatic Assay 08057826190

  URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM
  1 report

Recent Homocysteine Enzymatic Assay adverse event reports

The 1 most recent reports across all models, 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 ↗

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