ONLINE TDM Phenytoin 08445567190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336157787), received between Oct 12, 2023 and Feb 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K030428, K230161); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 12 PATIENT SAMPLES TESTED WITH ONLINE TDM PHENYTOIN - FREE PHENYTOIN APPLICATION ON A COBAS C 503 ANALYTICAL UNIT. PLEASE REFER TO THE ATTACHMENT FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455671 ↗
• MalfunctionOct 12, 2023Low Test Results; Low Readings; Low Test Results; Low Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE PHNY2 PHENYTOIN RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT. THE DOCTOR CONTESTED THE INITIAL RESULT BECAUSE A PHENYTOIN DOSE WAS GIVEN TO THE PATIENT, PROMPTING THE RERUN OF THE INITIAL PATIENT SAMPLE. A NEW SAMPLE WAS ALSO COLLECTED FROM THE PATIENT. THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 0.000000 UMOL/L WITH A DATA FLAG. THE FIRST REPEAT RESULT OF THE INITIAL SAMPLE WAS 3.06 UMOL/L WITH A DATA FLAG. THE SECOND REPEAT RESULT OF THE INITIAL SAMPLE WAS 3.21 UMOL/L WITH A DATA FLAG. THE INITIAL RESULT OF THE NEW SAMPLE WAS 0.0000 UMOL/L WITH A DATA FLAG. THE REPEAT RESULT OF THE NEW SAMPLE WITH DILUTION WAS 0.0000 UMOL/L WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919236 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030428, K230161. One submission often covers many models, so check the product and lot details in each record.

• Z-1062-04 · Jun 18, 2004 · Terminated
  Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Pro
• Z-1063-04 · Jun 18, 2004 · Terminated
  Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Prod