VIDAS® Measles IgG 30219Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03573026064532), received between Aug 17, 2018 and Sep 14, 2022 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (15 reports).

2 FDA recall records name this device's identifier, 2 still open.

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-0796-2023 · Root cause: Storage · Recall details · FDA record ↗

2. 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-0430-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2022Non Reproducible Results; Non Reproducible Results

  A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX THAT HE OBTAINED A NEGATIVE RESULT WHEN TESTING EXTERNAL QUALITY CONTROL WITH VIDAS MEASLES IGG 60TESTS(REF. 30219, BATCH NUMBER: 1009294550, EXPIRY DATE: 08 FEB 2023). THE CUSTOMER REPORTED DISCREPANCIES FOR THE BELOW RCPAQAP PROGRAM: RCPAQAP SURVEY 2 SAMPLE: SE-ME-22-04 ORIGINAL RESULT BY LABORATORY: 0.48, RFV 741, INTERPRETATION = NEGATIVE. LOT NUMBER: 1009294550 THE CUSTOMER PERFORMED A RETEST WITH ANOTHER LOT, HE OBTAINED: REPEAT RESULTS BY LABORATORY 0.65, RFV 763. INTERPRETATION: EQUIVOCAL. LOT NUMBER: 1009304060. THE EXPECTED RESULT WERE POSITIVE. AS IT WAS AN EXTERNAL QUALITY CONTROL, THERE IS NO PATIENT HARMED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417574 ↗
• MalfunctionMay 26, 2022False Negative Result; False Negative Result

  PRODUCT DESCRIPTION. VIDAS® MEASLES IGG (MSG) IS AN AUTOMATED QUALITATIVE TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS FAMILY, FOR THE DETECTION OF IGG ANTIBODIES TO MEASLES (RUBEOLA) VIRUS IN HUMAN SERUM USING THE ELFA TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). A TEST VALUE IS GENERATED FOR EACH SAMPLE BY FORMING A RATIO FROM THE RFV OF THE SAMPLE TO THAT OF A STANDARD. TEST VALUES FROM PATIENT AND CONTROL SAMPLES ARE COMPARED TO A SET OF THRESHOLDS STORED IN THE COMPUTER REPRESENTING A LOW MEASLES ANTIBODY TITER. THE FOLLOWING TABLE SHOWS THE THRESHOLDS AND THE INTERPRETED RESULTS. TEST VALUE INTERPRETATION 0.50 NEGATIVE. 0.50 TO < 0.70 EQUIVOCAL. 0.70 POSITIVE. ISSUE DESCRIPTION. ON (B)(6) 2021, A CUSTOMER FROM AUSTRALIA REPORTED TO BIOMÉRIEUX THAT HE OBTAINED AN EQUIVOCAL RESULT AND A FALSE NEGATIVE RESULT WHEN TESTING EXTERNAL QUALITY CONTROL WITH VIDAS MEASLES IGG 60TESTS (B)(4). 30219, BATCH NUMBER: 1008890110, EXPIRY DATE: 16 JUN 2022. THE CUSTOMER TESTED A QUALITY CONTROL SAMPLE DURING A CHALLENGE MANAGED BY RCPAQAP PROGRAM; HE OBTAINED THE FOLLOWING RESULTS: SAMPLE ID: SE-ME-22-01. CUSTOMER REPORTED AN EQUIVOCAL RESULT (0.61 TV). TO BE NOTED, ACCORDING TO THE IFU, AN EQ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518928 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847924 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847923 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847922 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847921 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847919 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847915 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847913 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847910 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847909 ↗
• MalfunctionMar 18, 2020False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG 60TESTS (REF. 30219, LOT 1007322860). THE CUSTOMER STATED SEVENTEEN PATIENTS WERE TESTED USING VIDAS® MEASLES IGG 60TESTS LOT 1007322860 AND USING THE VIROTECH TEST METHOD. SEVEN (7) PATIENTS HAD NO INTERPRETATION CHANGE IN THEIR RESULTS. TEN (10) PATIENTS OBTAINED A NEGATIVE RESULT WITH THE VIDAS® VIDAS® MEASLES IGG 60TESTS AND A POSITIVE RESULT USING VIROTECH. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847905 ↗
• MalfunctionFeb 27, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS FOR TWO NEQAS SURVEY STRAINS IN ASSOCIATION WITH VIDAS® MEASLES IGG (REF. 30219 LOT 1007322860). BOTH SURVEY STRAINS WERE TESTED IN DUPLICATE, RESULTS WERE: NEQAS STRAIN 5248: 0.4, 0.42 NEGATIVE; NEQAS STRAIN 5249: 0.49, 0.40 NEGATIVE. IT WAS CONFIRMED THE EXPECTED RESULT FOR BOTH NEQAS SURVEY STRAINS WAS POSITIVE. AS THERE ARE NO PATIENTS ASSOCIATED WITH THESE QUALITY CONTROL STRAINS, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 9765946 ↗
• InjuryOct 23, 2019False Negative Result; False Negative Result

  A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE PATIENT RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG ASSAY. VIDAS MEASLES IGG (MSG) IS AN AUTOMATED QUALITATIVE TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS FAMILY, FOR THE DETECTION OF IGG ANTIBODIES TO MEASLES (RUBEOLA) VIRUS IN HUMAN SERUM USING THE ELFA TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). ONCE THE ASSAY IS COMPLETED, RESULTS ARE ANALYZED AUTOMATICALLY BY THE COMPUTER. FLUORESCENCE IS MEASURED TWICE IN THE REAGENT STRIP'S READING CUVETTE FOR EACH SAMPLE TESTED. THE FIRST READING IS A BACKGROUND READING OF THE SUBSTRATE CUVETTE BEFORE THE SPR IS INTRODUCED INTO THE SUBSTRATE. THE SECOND READING IS TAKEN AFTER INCUBATING THE SUBSTRATE WITH THE ENZYME REMAINING ON THE INTERIOR OF THE SPR. THE RFV (RELATIVE FLUORESCENCE VALUE) IS CALCULATED BY SUBTRACTING THE BACKGROUND READING FROM THE FINAL RESULT. THIS CALCULATION APPEARS ON THE RESULT SHEET. A TEST VALUE IS GENERATED FOR EACH SAMPLE BY FORMING A RATIO FROM THE RFV OF THE SAMPLE TO THAT OF A STANDARD. TEST VALUES FROM PATIENT AND CONTROL SAMPLES ARE COMPARED TO A SET OF THRESHOLDS STORED IN THE COMPUTER REPRESENTING A LOW MEASLES ANTIBODY TITER. THE FOLLO

  Patient problems: Misdiagnosis

  MAUDE report 9224266 ↗
• MalfunctionOct 23, 2019False Negative Result; False Negative Result

  A CUSTOMER FROM THE (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE PATIENT RESULTS IN ASSOCIATION WITH THE VIDAS® MEASLES IGG ASSAY. VIDAS MEASLES IGG (MSG) IS AN AUTOMATED QUALITATIVE TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS FAMILY, FOR THE DETECTION OF IGG ANTIBODIES TO MEASLES (RUBEOLA) VIRUS IN HUMAN SERUM USING THE ELFA TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). ONCE THE ASSAY IS COMPLETED, RESULTS ARE ANALYZED AUTOMATICALLY BY THE COMPUTER. FLUORESCENCE IS MEASURED TWICE IN THE REAGENT STRIP'S READING CUVETTE FOR EACH SAMPLE TESTED. THE FIRST READING IS A BACKGROUND READING OF THE SUBSTRATE CUVETTE BEFORE THE SPR IS INTRODUCED INTO THE SUBSTRATE. THE SECOND READING IS TAKEN AFTER INCUBATING THE SUBSTRATE WITH THE ENZYME REMAINING ON THE INTERIOR OF THE SPR. THE RFV (RELATIVE FLUORESCENCE VALUE) IS CALCULATED BY SUBTRACTING THE BACKGROUND READING FROM THE FINAL RESULT. THIS CALCULATION APPEARS ON THE RESULT SHEET. A TEST VALUE IS GENERATED FOR EACH SAMPLE BY FORMING A RATIO FROM THE RFV OF THE SAMPLE TO THAT OF A STANDARD. TEST VALUES FROM PATIENT AND CONTROL SAMPLES ARE COMPARED TO A SET OF THRESHOLDS STORED IN THE COMPUTER REPRESENTING A LOW MEASLES ANTIBODY TITER. THE F

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9224265 ↗
• MalfunctionApr 17, 2019False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS FOR AN EXTERNAL STRAIN (EEQ CTCB) IN ASSOCIATION WITH THE VIDAS® MEASLES IGG ASSAY. THE SAMPLE WAS EXPECTED TO PROVIDE A POSITIVE RESULT BASED ON DIASORIN XL RESULTS OBTAINED DURING THE PRE-DISTRIBUTION TESTING. TWELVE (12) VIDAS USERS WERE INVOLVED IN THIS CHALLENGE; SEVEN (7) OF THEM REPORTED A NEGATIVE RESULT AND FIVE (5) REPORTED AN EQUIVOCAL RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE CTCB STRAIN. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8522517 ↗
• MalfunctionAug 17, 2018False Negative Result; False Negative Result

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS WHEN TESTING WITH VIDAS® MEASLES IGG (MSG), REF 30219, FOR A LAB QUALITY CAMPAIGN. FOR THE SAMPLE (B)(6), THE CUSTOMER OBTAINED ON THE VIDAS 3 INSTRUMENT : FIRST RESULT, TEST VALUE =0.48, NEGATIVE. SECOND RESULT (REPETITION OF THE TEST), TEST VALUE= 0.42 NEGATIVE. THE RESULT EXPECTED FOR THIS SAMPLE WAS POSITIVE. THE EXPECTED INTERPRETATION FOR S002 WAS OLD IMMUNITY OR VACCINATED ON LAB QUALITY'S REPORT. CONCERNING THIS LAB QUALITY CAMPAIGN, THERE WERE 50 PARTICIPANTS. THE RESULTS WERE : EIGHT (8) OF THEM REPORTED A NEGATIVE RESULT. FOUR (4) OF THEM REPORTED BORDERLINE RESULT. AND 38 REPORTED POSITIVE RESULT. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Patient Involvement

  MAUDE report 7794435 ↗