ONLINE TDM Vancomycin Gen.3 08058849190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613336121627), received between Dec 28, 2022 and Feb 12, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K152245); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ONLINE TDM VANCOMYCIN GEN. 3 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. SAMPLE 1'S INITIAL RESULT WAS 23 UG/ML. THE FIRST REPEAT RESULT WAS 1.52 UG/ML, ACCOMPANIED BY A DATA FLAG. THE SECOND REPEAT RESULT WAS 13.3 UG/ML. THIS SAMPLE WAS SENT TO ANOTHER LABORATORY, AND THE RESULT ON AN UNSPECIFIED ANALYZER WAS 50 UG/ML. THE SAMPLE WAS REPEATED AFTER A 1:2 DILUTION, AND THE RESULT WAS 44 UG/ML. SAMPLE 2'S INITIAL RESULT WAS 7 UG/ML. THE FIRST REPEAT RESULT WAS 0.0839 UG/ML, ACCOMPANIED BY A DATA FLAG. THE SECOND REPEAT RESULT WAS 19.9 UG/ML. SAMPLE 3'S INITIAL RESULT WAS 4 UG/ML. SAMPLE 4'S INITIAL RESULT WAS 2.11 UG/ML, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 17.2 UG/ML. TWO OF THE SAMPLES WERE RAN ON THE COBAS C 503 ANALYTICAL UNIT. THE OTHER TWO SAMPLES WERE RAN ON A DIFFERENT MODULE THAT WAS NOT SPECIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324670 ↗
• MalfunctionAug 19, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE VANC3 VANCOMYCIN RESULTS FOR 3 PATIENT SERUM SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THE DOCTOR QUESTIONED THE INITIAL LOW RESULTS WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLES. FOR SAMPLE 1, THE INITIAL VANC3 RESULT WAS <4 UG/ML WITH FLAG. THE SAMPLE WAS REPEATED ON ANOTHER C502 ANALYZER AND THE RESULT WAS 19.3 UG/ML. FOR SAMPLE 2, THE INITIAL VANC3 RESULT WAS <4 UG/ML WITH FLAG. THE SAMPLE WAS REPEATED ON ANOTHER C502 ANALYZER AND THE RESULT WAS 8.1 UG/ML. FOR SAMPLE 3, THE INITIAL VANC3 RESULT WAS <4 UG/ML WITH FLAG. THE SAMPLE WAS REPEATED ON ANOTHER C502 ANALYZER AND THE RESULT WAS 8.1 UG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999472 ↗
• MalfunctionDec 27, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE VANC3 VANCOMYCIN RESULTS FROM FIVE PATIENT SAMPLES TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS WERE QUESTIONED BY THE PHYSICIAN AS HIGHER RESULTS WERE EXPECTED, PROMPTING THE RERUN OF THE PATIENT SAMPLES. SAMPLE 1. THE INITIAL RESULT WAS 6 UG/ML. THE REPEAT RESULT WAS 10 UG/ML. SAMPLE 2. THE INITIAL RESULT WAS 6 UG/ML. THE REPEAT RESULT WAS 14 UG/ML. SAMPLE 3. THE INITIAL RESULT WAS 6 UG/ML. THE REPEAT RESULT WAS 12 UG/ML. SAMPLE 4. THE INITIAL RESULT WAS 6 UG/ML. THE REPEAT RESULT WAS 16 UG/ML. SAMPLE 5. THE INITIAL RESULT WAS 4 UG/ML. THE REPEAT RESULT WAS 16 UG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397226 ↗
• MalfunctionOct 4, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE VANC2 VANCOMYCIN RESULTS FOR 5 SAMPLES FROM THE SAME PATIENT ON A COBAS PRO C 503 ANALYTICAL UNIT. FOR SAMPLE 1, THE INITIAL RESULT WAS 14.1 MG/L. THE SAMPLE WAS REPEATED IN ANOTHER LABORATORY AND THE RESULT WAS 63.7 MG/L. FOR SAMPLE 2, THE INITIAL RESULT WAS 7.9 MG/L. THE SAMPLE WAS REPEATED IN ANOTHER LABORATORY AND THE RESULT WAS 38.4 MG/L. FOR SAMPLE 3, THE INITIAL RESULT WAS < 4 MG/L. THE SAMPLE WAS REPEATED IN ANOTHER LABORATORY AND THE RESULT WAS 7.5 MG/L. FOR SAMPLE 4, THE INITIAL RESULT WAS < 4 MG/L. THE SAMPLE WAS REPEATED IN ANOTHER LABORATORY AND THE RESULT WAS 7.5 MG/L. FOR SAMPLE 5, THE INITIAL RESULT WAS 11.7 MG/L. THE SAMPLE WAS REPEATED IN ANOTHER LABORATORY AND THE RESULT WAS 47.1 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869812 ↗
• MalfunctionJan 19, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLY LOW VANC3 VANCOMYCIN RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL VANC3 RESULT WAS 6.5. THE REPEAT RESULT WAS 9.5. THE SAMPLE WAS RE-CENTRIFUGED AND THE SECOND REPEAT RESULT WAS 9.5. THE SAMPLE WAS REPEATED AGAIN ON A FUJIREBIO ANALYZER AND THE RESULT WAS 11.0. THE UNITS OF MEASUREMENT WERE REQUESTED BUT NOT PROVIDED. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16209913 ↗
• MalfunctionDec 28, 2022Low Readings; Low Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF SAMPLES TESTED WITH THE VANC3 (ONLINE TDM VANCOMYCIN GEN. 3) ASSAY ON A COBAS C 503 ANALYTICAL UNIT, SERIAL NUMBER (B)(4). NO SPECIFIC DATA ON PATIENT RESULTS BEING AFFECTED WERE PROVIDED. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059991 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152245. One submission often covers many models, so check the product and lot details in each record.

• Z-0043-2020 · Jul 23, 2019 · Terminated
  Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
• Z-0042-2020 · Jul 23, 2019 · Terminated
  Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502