VIDAS® D-Dimer Exclusion II ™ 30455-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026387006), received between Aug 26, 2019 and Jan 15, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K141133); 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.

Recalls naming this device

1. Sep 22, 2021Class IIOpen, Classified

   bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

   Z-0427-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionJan 15, 2021Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING UNDERESTIMATED RESULTS WHEN TESTING AN EXTERNAL QUALITY CONTROL SAMPLE USING THEIR VIDAS® 3 INSTRUMENT (REF. 414356, SERIAL NUMBER (B)(4)) AND VIDAS® D DIMER EXCLUS II 60T US TEST KIT (REF. 30455-01). THE LOT NUMBER FOR THE ASSAY WAS NOT PROVIDED. THE CUSTOMER OBTAINED RESULTS BETWEEN 1-2 STANDARD DEVIATIONS BELOW THE EXPECTED RESULT ACCORDING TO QC NET. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIUEX CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER TO OBTAIN LAB REPORTS AND IMPACTED LOT NUMBERS; TO DATE THE CUSTOMER HAS NOT PROVIDED A RESPONSE. IT IS CURRENTLY UNKNOWN IF THE UNDERESTIMATED RESULTS OBTAINED BY THE CUSTOMER RESULTED IN AN INTERPRETATION CHANGE OF THE RESULTS. THE CUSTOMER ALSO TESTED AN EXTERNAL QUALITY CONTROL PROCALCITONIN SAMPLE USING THEIR VIDAS® 3 INSTRUMENT (REF. 414356, SERIAL NUMBER (B)(4)) AND OBTAINED PASSING RESULTS. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 11181548 ↗
• MalfunctionAug 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED OUT OF RANGE LOW RESULTS FOR PROFICIENCY SAMPLES FROM THE AMERICAN PROFICIENCY INSTITUTE (API) IN ASSOCIATION WITH THE VIDAS® D DIMER EXCLUSION¿ II ASSAY. THE CUSTOMER REPORTED THE CARDIAC MARKER TEST OF SAMPLES CM-06 AND CM-08 FOR THE D-DIMER RECEIVED A GRADE OF UNACCEPTABLE (60%). THE EXPECTED RESULT FOR SAMPLE CM-06 WAS 0.375-0.543UG FEU/ML AND THE CUSTOMER REPORTED 0.374UG FEU/ML. THE EXPECTED RESULT FOR SAMPLE CM-08 WAS 1.388-1.987UG FEU/ML AND THE CUSTOMER REPORTED 1.364UG FEU/ML. THE SAMPLES WERE REPEATED WITH A DIFFERENT STRIP LOT AND WERE IN RANGE, IN WHICH SAMPLE CM-06 WAS 0.471UG FEU/ML. AND CM-08 WAS 1.678UG FEU/ML. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A PROFICIENCY SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8933393 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141133. One submission often covers many models, so check the product and lot details in each record.

• Z-0797-2023 · Nov 9, 2022 · Open, Classified
  VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
• Z-0864-2023 · Nov 9, 2022 · Open, Classified
  VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
• Z-0928-2020 · Oct 22, 2019 · Terminated
  BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation