VIDAS® HCG 30405-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026156923), received between Apr 15, 2022 and Aug 25, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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

3 other recalls cover devices cleared under the same FDA submission (K141133, K921302); 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. Nov 9, 2022Class IIOpen, Classified

   As the temperature and time out of range was exceeded, product performances cannot be guaranteed

   Z-0864-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2022Non Reproducible Results; Non Reproducible Results

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX THAT THEY OBSERVED NON REPEATABLE UNDERESTIMATED RESULTS WHEN TESTING A PATIENT¿S SAMPLES USING VIDAS HCG 60 TESTS (LOT 1009059670, EXPIRY DATE 29-OCT-2022). ON (B)(6) 2022. THE PATIENT¿S FIRST SAMPLE WAS DRAWN ON (B)(6) 2022 AND TESTED WITH THE RESULT : 133.81 MUI/ML. THIS SAMPLE WAS RETESTED ON (B)(6) 2022 AND THE RESULT WAS 33.33 MUI/ML. THE SAME SAMPLE WAS STORED IN THE FRIDGE AND TESTED ON (B)(6) 2022: 4050 MUI/ML AND 4000 MUI/ML ON SECTION B. A NEW SAMPLE WAS DRAWN AND TESTED ON (B)(6) 2022. THE RESULTS FOR THIS SAME SAMPLE AFTER DILUTION B 1/20 WERE THE FOLLOWING: - RESULT 10:43 AM IN A2 POSITION: 5974.59 MUI/ML - RESULT AT 11:15 AM IN B2 POSITION: 6494.57 MUI/ML THE CUSTOMER STATED THAT THEY ARE CONCERNED THERE IS TOO MUCH DIFFERENCE BETWEEN THE RESULTS OBTAINED WITH THE FIRST SAMPLE AND THE SECOND AND NOT SURE IF THIS PATIENT IS CONSIDERED PREGNANT. THESE RESULTS WERE PRECEDED BY A VALID CALIBRATION PERFORMED ON (B)(6) 2022. THE LAST QCV RESULTS ON (B)(6) 2022 ON SECTIONS A AND B, SHOW THAT THERE IS NO PROBLEM WITH THE MINI VIDAS INSTRUMENT. AT THE TIME OF THIS ASSESSMENT, THERE WAS NO INDICATION THAT ANY PATIENT HARM OCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15296956 ↗
• MalfunctionJun 9, 2022High Test Results; High Test Results

  A CUSTOMER FROM UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING OVERESTIMATED RESULT WHEN TESTING EXTERNAL QUALITY CONTROL ON VIDAS HCG 60 TESTS (REF. 30405-01, BATCH NUMBER: 1009059670, EXPIRY DATE: 29-OCT 2022). THE CUSTOMER REPORTED THAT THE EXTERNAL CONTROLS LEVEL 3 RESULT WAS TOO HIGH WHEN ANALYZED WITH VIDAS HCG 60 TESTS (REF. 30405-01, BATCH NUMBER: 1009059670). THE CUSTOMER DID NOT PROVIDE THE RESULT OBTAINED AND EXPECTED WITH THE EXTERNAL CONTROLS LEVEL 3. THE CUSTOMER ALSO MENTIONED THAT THE CONTROLS PROVIDED IN THE VIDAS KIT WERE CONFORM. THE CUSTOMER ALSO COMPARED THESE EXTERNAL RESULTS WITH ANOTHER INSTRUMENT THAT'S NOT A MINIVIDAS. FOLLOWING THIS ISSUE, THE CUSTOMER REQUESTED AN FSE (FIELD SERVICE ENGINEER) TO BE DISPATCHED ON SITE. AS IT WAS AN EXTERNAL QUALITY CONTROL, NO PATIENT SAMPLE WAS INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644522 ↗
• MalfunctionApr 15, 2022Low Test Results; Low Test Results

  A CUSTOMER IN THE UNITED STATES REPORTED TO BIOMÉRIEUX THAT THEY OBSERVED NON REPEATABLE UNDERESTIMATED RESULTS WHEN TESTING PATIENT SAMPLES USING VIDAS® HCG 60 TESTS (REF. 30405-01, LOT 1009059670, EXPIRY DATE = 29-OCT-2022) COMPARED TO ANOTHER BATCH. THE RESULTS WERE: RESULT ON (B)(6) 2022 AT 04:02 PM FOR A NEW SAMPLE OF THE SAME PATIENT USING VIDAS HCG 60 TESTS LOT 1009059670: (B)(6). RESULT ON (B)(6) 2022 FOR A NEW SAMPLE OF THE SAME PATIENT USING VIDAS HCG 60 TESTS LOT 1009059670: (B)(6). RESULT ON (B)(6) 2022 FOR A NEW SAMPLE OF THE SAME PATIENT USING VIDAS HCG 60 TESTS LOT 1009059670 : (B)(6). THESE RESULTS WERE PRECEDED BY A VALID CALIBRATION PERFORMED ON THE (B)(6) 2022. THE ONLY INFORMATION AVAILABLE AT THE TIME OF THIS ASSESSMENT REGARDING THE PATIENT IS THAT SHE WAS NOT TRYING TO GET PREGNANT. THE CUSTOMER REPORTED THAT THEY PERFORM QCV WEEKLY AND THAT IT WAS CONFORM. AT THE TIME OF THIS ASSESSMENT, THERE WAS NO INDICATION THAT ANY PATIENT HARM OCCURRED AS A RESULT FO THIS ISSUE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121086 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141133, K921302. 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-0427-2022 · Sep 22, 2021 · Open, Classified
  VIDAS DEX@, Dimer Exclusion II, REF 30455-01
• Z-0928-2020 · Oct 22, 2019 · Terminated
  BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation