VIDAS® Varicella-Zoster IgG 30217Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03573026064518), received between May 1, 2018 and Nov 26, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (4 reports).

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

1 other recall cover devices cleared under the same FDA submission (K923122); 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-0795-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024False Negative Result; False Negative Result

  ON (B)(6) 2024, A CUSTOMER IN SWITZERLAND NOTIFIED BIOMÉRIEUX OF A POTENTIAL FALSE NEGATIVE PATIENT RESULT COMPARED TO ANOTHER METHOD (DIASORIN) WHEN USING VIDAS® VARICELLA-ZOSTER IGG (VZG) REFERENCE (B)(4) LOT 1010385660 (EXPIRY 05-SEP-2024). PATIENT INFORMATION: ELDERLY FEMALE IN A MEDICO-SOCIAL ESTABLISHMENT. TESTING WAS PERFORMED TO RECHECK IMMUNITY, AS THERE ARE PEOPLE INFECTED INSIDE THE ESTABLISHMENT. THE ISSUE OCCURRED IN (B)(6) 2024 (TESTING (B)(6)2024). THE CUSTOMER REPORTED A SUSPECTED FALSE NEGATIVE RESULT WHEN TESTING A PATIENT'S SAMPLE WITH RESULT OF 0.59 TV (AT THE UPPER LIMIT OF NEGATIVE INTERPRETATION). OTHER METHOD (DIASORIN) RESULTS WERE REPORTED POSITIVE ON (B)(6) 2024. AT THE TIME OF THIS ASSESSMENT, THERE IS NO INDICATION OF PATIENT HARM, INCORRECT TREATMENT, NOR DELAY IN RENDERING RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20781169 ↗
• MalfunctionFeb 5, 2024False Negative Result; False Negative Result

  ON 31-JAN-2024, A CUSTOMER FROM GERMANY NOTIFIED BIOMÉRIEUX OF OBTAINING NEGATIVE RESULT WHEN TESTING PATIENT SAMPLE WITH VIDAS VARICEL. ZOSTER IGG 60 T (REF. 30217, BATCH NUMBER: 1010193850, EXPIRY DATE: 26-MAY-2024) COMPARED TO ANOTHER METHOD. THE CUSTOMER USES A MINI VIDAS® INSTRUMENT (SERIAL NO. (B)(6)). ACCORDING TO THE INFORMATION PROVIDED, THE TESTING WAS PERFORMED ON A 32 YEAR OLD PREGNANT WOMAN. INSTRUMENT: MINI VIDAS® 5.6.1 LAST PREVENTATIVE MAINTENANCE: 15FEB2023 QCV TEST RUN THE (B)(6) 2023 WAS COMPLIANT. QCV TEST RUN THE (B)(6) 2023 WAS COMPLIANT. MLE DATA VZ IGG REF 30217, LOT: 1010193850 S1: 447 ¿ 829 RFV C1: 1.97 ¿ 2.85 C2: <= 0.59 CALIBRATION PERFORMED THE 07NOV2023 = > VALID S1: 701/640 RFV, MEAN: 670 RFV. C1: 2.47 (1657 RFV) POSITIVE C2: 0.00 (-1 RFV) NEGATIVE CALIBRATION PERFORMED ON 04JAN2024 = > VALID S1: 692 / 675 RFV, MEAN: 683 RFV C1: 2.49 (1701 RFV) POSITIVE C2: 0.00 (0 RFV) NEGATIVE PATIENT SAMPLE TESTING: VZ IGG TESTING WITH VIDAS LOT 1010193850 PERFORMED ON (B)(6) 2023; PERFORMED WITH CALIBRATION VALID FROM 07NOV2023. RESULT: (0.50) NEG VZ IGG TESTING WITH VIDAS LOT 1010193850 PERFORMED ON (B)(6) 2024; PERFORMED WITH CALIBRATION VALID FROM 04JAN2024. RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18644697 ↗
• MalfunctionDec 18, 2023False Negative Result; False Negative Result

  ON (B)(6) 2023, A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING NEGATIVE RESULT WHEN TESTING PATIENT SAMPLE WITH VIDAS VARICEL. ZOSTER IGG 60 T (REF. 30217, BATCH NUMBER: 1009987800, EXPIRY DATE: 21-JAN-2024) COMPARED TO ANOTHER METHOD. THE CUSTOMER PERFORMED TEST ON ONE (1) PATIENT SAMPLE, HE OBTAINED THE FOLLOWING RESULTS: PATIENT TEST ON (B)(6) 2023 : 0.46 TV (NEGATIVE RESULT). HE COMPARED WITH ANOTHER METHOD (TEST ON LIAISON DIASORIN) : 212 MUI/ML. NEG < 50 MUI/ML. EQUIV 50 - 100 MUI/ML. TRACES 101 - 150 MUI/ML. POS > 150 MUI/ML. CALIBRATION WAS DONE 06-OCT-2023 AND WAS VALID. S1 : 670/672 RFV [481-894] RFV. C1 : 1469 RFV -> 2.18 VT [1.92-2.78] TV. C2 : 0 <0.59 TV. AT THE TIME OF THIS ASSESSMENT, THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING CLINICAL CONTEXT, DELAY RESULT OR ANY INDICATION OF PATIENT IMPACT. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344161 ↗
• MalfunctionSep 29, 2022False Positive Result; False Positive Result

  ON (B)(6) 2022, AN INTERNAL BIOMÉRIEUX COMPLAINT WAS OPENED BECAUSE THE COMPLAINTS LABORATORY OBTAINED FALSE POSITIVE RESULTS WHEN TESTING EXTERNAL QUALITY CONTROL WITH VIDAS VARICEL. ZOSTER IGG 60 T (REF. 30217, BATCH NUMBER: 1009002790, EXPIRY DATE:(B)(6) 2022). THIS LOT IS NOW EXPIRED. THE COMPLAINTS LABORATORY OBTAINED A POSITIVE RESULT FOR (B)(6). WHILE THE SAMPLE WAS INTENDED NEGATIVE. SAMPLE ID (B)(6).: 1.94 TV, POSITIVE THE RESULTS OBSERVED FOR THE SAMPLES ID (B)(6). (POSITIVE), ID (B)(6) (POSITIVE), ID (B)(6). (POSITIVE), ID (B)(6). (POSITIVE) AND ID (B)(6). (POSITIVE) COMPLIED TO THE EXPECTED INTERPRETATION. THERE IS NO PATIENT ASSOCIATED WITH THIS EXTERNAL QC SAMPLE; THEREFORE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503571 ↗
• InjuryJul 1, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULT WHEN TESTING PATIENT SAMPLE WITH VIDAS® VARICEL. ZOSTER IGG 60 T (REF. (B)(4), BATCH NUMBER: 1009111670, EXPIRY DATE: 14-SEP-2022) COMPARED TO ANOTHER METHOD. THE LABORATORY PERFORMED VZG IGG TESTS ONLY FOR EMERGENCIES OF PREGNANT WOMEN / POST-PARTUM. THE CUSTOMER OBTAINED THE FOLLOWING RESULTS WITH VIDAS VARICEL. ZOSTER IGG (REF. (B)(4)) AND WITH LIAISON: PATIENT A: VIDAS: NEGATIVE / LIAISON: POSITIVE. FOLLOWING PATIENT A RESULT FROM (B)(6) 2022, THE TESTED MOTHER'S BABY WAS HOSPITALIZED AND ACCORDING TO THE PHARMACIST, PROBABLY RECEIVED INAPPROPRIATE TREATMENT. FOR THE BABY OF THE PATIENT A: HE WAS TRANSFERRED TO NEONATOLOGY AT DAY 0 FOR 4 DAYS FOR HIGH RISK OF MATERNAL PRIMARY VZ INFECTION. HE HAD IGG VZ IMMUNOGLOBULINS ON (B)(6) 2022 AND ACYCLOVIR (ACV) FROM (B)(6) 2022. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: Insufficient Information

  MAUDE report 14886059 ↗
• MalfunctionDec 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE VARICELLA-ZOSTER IGG (VZG)RESULT IN ASSOCIATION WITH THE VIDAS® VARICELLA-ZOSTER IGG 60 T (REF 30217). THE SPECIFIC LOT NUMBER WAS NOT PROVIDED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE NEGATIVE VZG RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9433916 ↗
• MalfunctionJul 17, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VIDAS® VARICEL ZOSTER IGG (REFERENCE 30217). THE CUSTOMER REPORTED DURING THE LAST (B)(6) DISTRIBUTION FOR IMMUNITY SCREEN SCHEME PARTICIPANTS USING BIOMÉRIEUX VIDAS ASSAY REPORTED EQUIVOCAL OR NEGATIVE VZV IGG RESULTS FOR SPECIMEN (B)(4) THAT WAS PREPARED FROM A SINGLE NEAT DONATION AND WAS POSITIVE FOR VZV IGG. IN PRE-DISTRIBUTION TESTING THE SPECIMEN WAS TESTED POSITIVE USING DIASORIN LIAISON, VIRION SERION, BINDING SITE VACCZYME QUANTITATIVE ASSAYS. SPECIMEN 4372 WAS TESTED EQUIVOCAL USING BIOMÉRIEUX VIDAS® ASSAY. READINGS FROM PRE-DISTRIBUTION AND FROM PARTICIPANTS' RESULTS SHOW THAT VZV IGG ANTIBODIES WERE PRESENT IN THE SPECIMEN. BELOW REFERENCES PRE-DISTRIBUTION TEST RESULTS FOR SPECIMEN (B)(4): BIOMÉRIEUX VIDAS VZG TV 0.74 EQUIVOCAL; DIASORIN 516.6 MIU/ML (POSITIVE CUT OFF 100;) VIRION SERION VZV IGG : 300.58 IU/ML (GREY ZONE 15.0-20.0); BONDING SITE VACCZYME VZV GLYCOPROTEIN IGG 207 MIU/ML (GREY ZONE 100-150). OUT OF THE 93 BIOMÉRIEUX VIDAS® USERS 84 (90.3%) REPORTED AN EQUIVOCAL RESULT, 7 (7.5%) REPORTED A NEGATIVE RESULT AND ONE (2.2%) USER REPORTED A POSITIVE RESULT FOR SPECIMEN (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7694066 ↗
• MalfunctionMay 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VIDAS® VARICELLA (IGG) (REFERENCE 30217). THE CUSTOMER REPORTED RUNNING THREE (3) PATIENT SAMPLES USING A NEW LOT OF PRODUCT AND THE RESULTS WERE: 1 NEGATIVE, 1 EQUIVOCAL AND 1 POSITIVE. THE RESULTS FOR SAMPLE NO. (B)(4) DURING THE WEEK OF (B)(6) 2018 ON THE OLD LOT WERE REPORTED AS 3.18. YESTERDAY ((B)(6) 2018) USING NEW LOT THE RESULT WAS 3.92 AND 3.25 WHILE RUNNING THE SAMPLE ON THE OLD LOT. THE RESULTS FOR SAMPLE NO. (B)(4) DURING THE WEEK OF (B)(6) 2018 ON THE OLD LOT WERE REPORTED AS 0.12. YESTERDAY ((B)(6) 2018) USING NEW LOT THE RESULT WAS 0.14 AND 0.13 WHILE RUNNING THE SAMPLE ON THE OLD LOT. THE RESULTS FOR SAMPLE NO. 184027728 DURING THE WEEK OF 26MAR2018 ON THE OLD LOT WERE REPORTED AS 0.80. YESTERDAY (04APR2018) USING NEW LOT THE RESULT WAS 1.05 AND 0.91 WHILE RUNNING THE SAMPLE ON THE OLD LOT. THE CUSTOMER IS CONCERNED WITH RESULTS FOR SAMPLE (B)(4). THE SAMPLE WAS REPORTED LAST WEEK AS AN EQUIVOCAL RESULT WITH A VALUE OF 0.80. YESTERDAY ((B)(6) 2018) ON THE NEW LOT THE RESULTS OBTAINED WERE 1.05. THE CUSTOMER IS CONCERNED THAT EQUIVOCAL RESULTS COULD BE REPORTED AS POSITIVES USING THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7476873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923122. One submission often covers many models, so check the product and lot details in each record.

• Z-1107-2020 · Dec 10, 2019 · Terminated
  VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit