NEO Iris 0064597Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10888234002321), received between May 15, 2019 and Apr 30, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (23 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF QUARTERLY EVENTS INDICATED FOURTEEN (14) EVENTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM WHERE A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046557 ↗
• MalfunctionJan 30, 2026False Negative Result; False Positive Result

  A REVIEW OF QUARTERLY EVENTS INDICATED ELEVEN (11) EVENTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM WHERE A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225617 ↗
• MalfunctionOct 31, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW OF QUARTERLY EVENTS INDICATED NINETEEN (19) EVENTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM WHERE A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442489 ↗
• MalfunctionJul 23, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW OF QUARTERLY EVENTS INDICATED TWENTY-TWO (22) EVENTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM WHERE A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573447 ↗
• MalfunctionJan 31, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW OF QUARTERLY EVENTS INDICATED 20 EVENTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM WHERE A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289228 ↗
• MalfunctionNov 5, 2024False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW INDICATED THAT IN EIGHT (8) EVENTS FOR SEVEN (7) DONOR SAMPLES AND TWO (2) PATIENT SAMPLES TESTED USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS. A REVIEW OF QUARTERLY EVENTS INDICATED THAT SEVEN (7) DONOR SAMPLES AND TWO (2) PATIENT SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: RH MISTYPE FOR ONE (1) DONOR SAMPLE; ABO MISTYPE FOR SIX (6) DONOR SAMPLES AND ONE (1) PATIENT SAMPLE; AND A MISSED ANTIBODY FOR ONE (1) PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611495 ↗
• MalfunctionOct 30, 2024False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW INDICATED THAT IN SEVEN (7) EVENTS FOR SIX (6) DONOR SAMPLES AND TWO (2) PATIENT SAMPLES TESTED USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS. A REVIEW OF QUARTERLY EVENTS INDICATED THAT SIX (6) DONOR SAMPLES AND TWO (2) PATIENT SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: RH MISTYPE FOR ONE (1) DONOR SAMPLE; ABO MISTYPE FOR FIVE (5) DONOR SAMPLES AND ONE (1) PATIENT SAMPLE; AND A MISSED ANTIBODY FOR ONE (1) PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575603 ↗
• MalfunctionApr 29, 2024False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW INDICATED THAT FOR THREE (3) DONOR SAMPLES TESTED USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS. A REVIEW OF QUARTERLY EVENTS INDICATED THAT THREE (3) DONOR SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: ABO MISTYPE FOR THREE (2) DONOR SAMPLES; AND UNEXPECTED ANTI-C FOR ONE (1) DONOR UNIT. ON (B)(6) 2024 A CUSTOMER REPORTED THAT THEY RECEIVED AN UNEXPECTED NEGATIVE ANTI-C RESULT ON THE NEO IRIS INSTRUMENT FOR ONE DONOR SAMPLE. CUSTOMER STATES THAT SAMPLE FROM A DONOR WAS REPORTED AS NEGATIVE USING ANTI-C LOT NUMBER 936235 ON NEO IRIS INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER STATES THAT THEY REPEATED SAMPLE USING ANTI-C LOT 936225 AND GOT NTD ON ON NEO IRIS INSTRUMENT SERIAL NUMBER (B)(6); CUSTOMER STATES THAT THEY RESUSPENDED AND RESPUN SAMPLE AND REPEATED AGAIN AND STILL RESULTED AS NTD. REPEAT TESTING IN REFERENCE LAB IDENTIFIED C+ IN SAMPLE. ON (B)(6) 2024 IMMUCOR USED REMOTE ACCESS TO REVIEW IMAGES OF THE AFFECTED PLATE; FLATFIELD WAS ACCEPTABLE. ON (B)(6) 2024 AN IMMUCOR FIELD SERVICE ENGINEER (FSE) INSPECTED NEO IRIS INSTRUMENT SERIAL NUMBER (B)(

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19208881 ↗
• MalfunctionJan 31, 2024False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW INDICATED THAT FOR THREE (3) DONOR SAMPLES TESTED USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS. A REVIEW OF QUARTERLY EVENTS INDICATED THAT THREE (3) DONOR SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: ABO MISTYPE FOR THREE (3) DONOR SAMPLES. ON OCTOBER 26, 2023 A CUSTOMER REPORTED THAT THEY RECEIVED AN UNEXPECTED ABO TYPING RESULTS ON THE NEO IRIS INSTRUMENT FOR ONE DONOR SAMPLE (THE ACTUAL DATE OF THE EVENT WAS NOT PROVIDED). CUSTOMER STATES THAT SAMPLE FROM A DONOR WHO IS HISTORICALLY A POS WAS REPORTED AS AB POS USING ANTI-B LOT NUMBER 203930 WITH THERMO SCIENTIFIC LOT NUMBER 676110 PREBUFFERED SALINE ON NEO IRIS INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER REPEATED TESTING MANUALLY WITH THE SAME REAGENT LOTS/DIFFERENT VIALS AND RESULTED A POS AS EXPECTED. CUSTOMER REPEATED SAMPLE ON NEO IRIS INSTRUMENT SERIAL NUMBER (B)(6) AND IT RESULTED A POS AS EXPECTED. ISSUE WAS POTENTIALLY CAUSED BY REAGENT SPLASHING DURING DISPENSE (INDICATED BY CUSTOMER BUT NOT VERIFIED). ON (B)(6) 2023 IMMUCOR USED REMOTE ACCESS TO REVIEW IMAGES OF THE AFFECTED PLATE; REAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616554 ↗
• MalfunctionOct 18, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW INDICATED THAT FOR THREE (3) PATIENT/DONOR SAMPLES TESTED USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.A REVIEW OF QUARTERLY EVENTS INDICATED THAT THREE (3) PATIENT/DONOR SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS: A MISSED ANTI-E DURING AN ANTIBODY SCREEN; A MISSED WEAK-D; AND UNEXPECTED NEGATIVE RESULTS FOR A 2-CELL SCREEN THAT FAILED TO DETECT A HISTORIC PAN AGGLUTIN AND AN ANTI-D.ON SEPTEMBER 15, 2023 A CUSTOMER REPORTED A MISSED ANTI-E WITH CAPTURE-R READY-SCREEN 3 LOT NUMBER R503 (EXPIRY SEPTEMBER 26, 2023) ON NEO IRIS INSTRUMENT SERIAL NUMBER (B)(6). SAMPLE WAS BEING USED FOR A CORRELATION STUDY WITH ECHO LUMENA INSTRUMENT SERIAL NUMBER M20485; THE ECHO LUMENA DETECTED THE ANTI-E. NO PATIENT INJURY OR HARM WAS REPORTED. ON SEPTEMBER 19, 2023 AN IMMUCOR FIELD SERVICE ENGINEER (FSE) INSPECTED NEO IRIS INSTRUMENT SERIAL NUMBER (B)(6) AT THE CUSTOMER SITE. THE FSE PERFORMED THE UNEXPECTED REACTION CHECKLIST SUCCESSFULLY. NO INSTRUMENT PROBLEM WAS IDENTIFIED. THE IMMUCOR INTERNAL REFERENCE FOR THE ASSOCIATED RECORD IS (B)(4).ON AUGUST 11, 2023 A C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962464 ↗
• MalfunctionJul 31, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW INDICATED THAT FIVER (5) DONOR SAMPLE TEST USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM MALFUNCTIONED, RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS. A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS; FOR ABO PHENOTYPING ((FWD ABORH ASSAY) IN TWO (2) INSTANCE (INVOLVING 2 DONOR SAMPLES), FOR CAPTURE-CMV IN ONE (1) INSTANCE (INVOLVING 1 DONOR SAMPLES), AND INACCURATE RESULTS FOR KNOWN ANTIBODIES IN TWO (2) INSTANCES (INVOLVING 2 PATIENT SAMPLES). A CMV ASSAY SAMPLE WAS UNEXPECTEDLY NEGATIVE DUE TO A CAMERA AND ROI RELATED ISSUE ON NEO IRIS INSTRUMENT SERIAL NUMBER (B)(6). NO ADVERSE EVENT OCCURRED. NO INCOMPATIBLE BLOOD PRODUCTS WERE TRANSFUSED. AN IMMUCOR FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND PERFORMED THE FOLLOWING ACTIONS: REVIEWED THE RESULTS IMAGES FOR THE SAMPLE IN QUESTION; PERFORMED AN AUTOMATIC CAMERA ADJUSTMENT AND TOOK NEW FLATFIELDS; ADJUSTED ROIS; INITIALIZED INSTRUMENT; RAN READER PERFORMANCE WITH AN IMPROVEMENT ON OVERALL VALUES DURING THE FINAL READ. A COMBINATION OF CAMERA READER AND WEAK POSITIVE SAMPLE CONTRIBUTED TO ERROR. INSTRUMENT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431211 ↗
• MalfunctionJul 26, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW INDICATED THAT FIVER (5) DONOR SAMPLE TEST USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM MALFUNCTIONED, RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS. A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS; FOR ABO PHENOTYPING ((FWD ABORH ASSAY) IN TWO (2) INSTANCE (INVOLVING 2 DONOR SAMPLES), FOR CAPTURE-CMV IN ONE (1) INSTANCE (INVOLVING 1 DONOR SAMPLES), AND INACCURATE RESULTS FOR KNOWN ANTIBODIES IN TWO (2) INSTANCES (INVOLVING 2 PATIENT SAMPLES). A CMV ASSAY SAMPLE WAS UNEXPECTEDLY NEGATIVE DUE TO A CAMERA AND ROI RELATED ISSUE ON NEO IRIS INSTRUMENT SERIAL NUMBER (B)(6). NO ADVERSE EVENT OCCURRED. NO INCOMPATIBLE BLOOD PRODUCTS WERE TRANSFUSED. AN IMMUCOR FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND PERFORMED THE FOLLOWING ACTIONS: REVIEWED THE RESULTS IMAGES FOR THE SAMPLE IN QUESTION; PERFORMED AN AUTOMATIC CAMERA ADJUSTMENT AND TOOK NEW FLATFIELDS; ADJUSTED ROIS; INITIALIZED INSTRUMENT; RAN READER PERFORMANCE WITH AN IMPROVEMENT ON OVERALL VALUES DURING THE FINAL READ. A COMBINATION OF CAMERA READER AND WEAK POSITIVE SAMPLE CONTRIBUTED TO ERROR. INSTRUMENT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401978 ↗
• MalfunctionApr 27, 2023False Negative Result; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR KNOWN ANTIBODIES IN TWO (2) INSTANCES (INVOLVING 2 PATIENT SAMPLES SAMPLES); ONE (1) ANTIBODY ID ERROR WAS ALSO REPORTED. A CUSTOMER REPORTS DONOR UNIT MISTYPE ON NEO IRIS SERIAL NUMBER (B)(6). DURING RETYPING OF DONOR UNITS CUSTOMER HAD RUN BNEG UNITS THEN NEXT SEQUENCE OF PIPETTING WAS OPOS UNITS. FIRST PIPETTOR GAVE BPOS FOR UNITS THAT SHOULD BE OPOS. SECOND PIPETTOR GAVE NTD POS INSTEAD OF OPOS. CUSTOMER REPEATED TESTING MANUALLY IN TUBE AND GOT O (RXN STRENGTH 0)- ANTI-A,B LOT 301610. CUSTOMER DOES NOT PERFORM MANUAL ANTI-D TESTING FOR KNOWN RHPOS UNITS. 2 UNITS THAT WERE TYPING INCORRECTLY WERE REPEATED AND RESULTED AS EXPECTED. THE REPEATS WERE PERFORMED ON THE SAME INSTRUMENT WITH THE SAME DONOR UNITS AND THE SAME REAGENT BOTTLES AND LOTS AND CAME BACK O POSITIVE AS EXPECTED ON THE SECOND RUN. AN IMMUCOR FIELD SERVICE ENGINEER REPLACED THE REAGENT PROBE AND SYRINGE PUMP AND THE ISSUE WAS RESOLVED. A CUSTOMER REPORTED A MISSED ANT-S ON A PATIENT SAMPLE WITH CAPTURE-R READY-SCREEN (I AND II) ON NEO IRIS INSTRUMENT SERIAL NUMBER (B)(6). SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828730 ↗
• MalfunctionJan 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT TWO (2) PATIENT SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR KNOWN ANTIBODIES INACCURATE RESULT # 1: A NEO IRIS MISSED THE ANTI-K ANTIBODY WITH THE CAPTURE-R READY SCREEN 3 AND THE CAPTURE-R READY ID ASSAY DURING AN INSTRUMENT VALIDATION STUDY. INACCURATE RESULT # 2: A NEO IRIS MISSED THE ANTI-C ANTIBODY WITH THE CAPTURE-R READY ID ASSAY. IN EACH CIRCUMSTANCE, SUBSEQUENT TESTING OF RELEVANT REAGENT RETENTION LOTS PRODUCED ACCURATE RESULTS. ADDITIONAL INVESTIGATIONS RELATED TO QUALITY CONTROL PROCESSES; TEST PROCEDURES AND OTHER FACTS COULD NOT DETERMINE ANY DIRECT CAUSE OF THE MISSED ANTIBODY SCREENINGS AND THE MALFUNCTIONS ARE ALLOCATED AGAINST THE ANALYTICAL INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275239 ↗
• MalfunctionOct 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF THE EVENTS INDICATED THAT FOUR (4) PATIENT SAMPLES TESTED ON THE NEO IRIS, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE ABO RESULTS. INACCURATE RESULT # 1: CUSTOMER REPORTS UNEXPECTED POSITIVE REACTION ON NEO IRIS SERIAL # (B)(4). THE ONE (1) SAMPLE PRODUCED A 4+ RESULT FOR ANTI-A. THE SAME SAMPLE TESTED IN TUBE AS NEGATIVE FOR ANTI-A. THE SAMPLE WAS TESTED AGAIN ON THE NEO IRIS AND PRODUCED A NEGATIVE RESULT FOR ANTI-A. CUSTOMER STATED THERE WERE 4 PATIENT SAMPLES IN THE RUN AND ONLY ONE SAMPLE HAD AN ISSUE. INACCURATE RESULT # 2: CUSTOMER STATED THEY HAD AN ISSUE WITH A NEO INSTRUMENT PRODUCING A PATIENT TYPING AS O POSITIVE. CUSTOMER STATED AS A NEW PATIENT, THEIR POLICY REQUIRES A SECOND SAMPLE BE TESTED. CUSTOMER STATED THE SECOND SAMPLE WAS TESTED ON AN ECHO AND GAVE AN A POSITIVE RESULT. CUSTOMER STATED THEY REPEATED THE INITIAL SAMPLE IN TUBE, ON THE NEO AND ECHO AND RECEIVED A RESULT OF A POSITIVE. CUSTOMER STATES THE SAMPLE WAS RUN AGAIN WITH SAME BATCH THAT IT WAS INITIALLY TESTED AND RECEIVED A RESULT OF A POSITIVE. INACCURATE RESULT # 3: NEO IRIS SERIAL # (B)(4) CUSTOMER REPORTED AN ABO DISCREPANCY CUSTOMER REPORTED OUTSIDE CONTRACT STATES PT HISTORY OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705264 ↗
• MalfunctionJul 29, 2022False Negative Result; False Negative Result

  A REVIEW OF THE EVENTS INDICATED THAT ONE PATIENT SAMPLE TESTED ON THE NEO IRIS, AUTOMATED BLOOD BANK SYSTEM PRODUCED AN INACCURATE RESULT. A REVIEW INDICATED THAT THE PATIENT SAMPLE TEST USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED COMPATIBLE CROSSMATCH. PATIENT SAMPLES CONDUCTED ON AN ECHO LUMINA AND IN PEG AND WERE INCOMPATIBLE. THE TEST RUN ON THE NEO IRIS RESULTED IN A COMPATIBLE RESULT. THE TESTING WAS CONDUCTED FOR CORRELATION STUDIES. THE UNEXPECTED COMPATIBLE CROSSMATCH WAS RESOLVED AFTER SPECIFIC MAINTENANCE AND RE-TESTING. SUBSEQUENT TESTING OF THE REAGENT RETENTION LOT, INCLUDING REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130296 ↗
• MalfunctionMay 2, 2022False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW OF THE EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE NEO IRIS, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT PATIENT SAMPLE TESTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED THREE FALSE NEGATIVE RESULTS FOR THE ANTI-K ANTIBODY; ONE FALSE NEGATIVE RESULT FOR THE ANTI-C ANTIBODY AND ONE FALSE NEGATIVE FOR THE ANTI-S ANTIBODY. ADDITIONALLY, ONE PATIENT SAMPLE PRODUCED A FALSE POSITIVE TEST RESULT FOR THE ANTI-K ANTIBODY. TWO INSTRUMENT MALFUNCTIONS PRODUCED INACCURATE ABO RESULTS USING THE ABO FORWARD TYPING ASSAY BASED ON A HISTORICAL RESULT FOR THE PATIENT. INACCURATELY TYPING ANTI-D AND ANTI-B. OUR INVESTIGATION DETERMINED THAT THE ANTI-D INACCURATE RESULT WAS PARTIALLY CAUSED BY OPERATOR ERRO; GIVEN THE FACT THAT NO ANTI-D REAGENT WAS PIPETTED DURING THE SAMPLE TEST RUN. IN ALL CASES, SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. NO SINGLE REASON FOR THE FALSE NEGATIVES, FALSE POSITIVE AND INACCURATE ABO OR RH RESULTS WAS DETERMINED AND THE MALFUNCTIONS WERE ALLOCATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14257533 ↗
• MalfunctionJan 31, 2022False Negative Result; False Negative Result

  A REVIEW OF THE EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE NEO IRIS, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT PATIENT SAMPLE TESTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED ONE (1) FALSE NEGATIVE RESULT FOR THE ANTI-E ANTIBODY; ONE (1) FALSE NEGATIVE RESULT FOR THE ANTI-K ANTIBODY AND ONE (1) FALSE NEGATIVE FOR THE ANTI-FYA ANTIBODY. THREE (3) INSTRUMENT MALFUNCTIONS PRODUCED INACCURATE ABO USING THE ABO FORWARD TYPING ASSAY BASED ON A HISTORICAL RESULT FOR THE PATIENT; INACCURATELY TYPING ANTI-D, ANTI-A AND ANTI-B. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. NO SINGLE REASON FOR THE FALSE NEGATIVES WERE DETERMINED AND THE MALFUNCTIONS WERE ALLOCATED AGAINST THE ANALYTICAL INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 13398045 ↗
• MalfunctionOct 29, 2021False Negative Result; False Negative Result

  A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLES TESTED ON THE NEO IRIS, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED ONE (1) FALSE NEGATIVE RESULT FOR THE ANTI-E ANTIBODY. TWO (2) INSTRUMENT MALFUNCTIONS PRODUCED INACCURATE ABORH RESULTS USING THE ABO FORWARD TYPING ASSAY BASED ON A HISTORICAL RESULT FOR THE PATIENT; INACCURATELY TYPING ANTI-A. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: Insufficient Information

  MAUDE report 12721246 ↗
• MalfunctionJul 30, 2021False Negative Result; False Negative Result

  A REVIEW OF THE EVENTS INDICATED THAT TWO PATIENT SAMPLES TESTED ON THE NEO IRIS, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM'S MALFUNCTIONS PRODUCED TWO INACCURATE ABO RH RESULTS USING THE ABO FORWARD TYPING ASSAY AND HISTORICAL RESULTS FOR THE PATIENTS; INACCURATELY TYPING ANTI-D AND ANTI-A. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: Insufficient Information

  MAUDE report 12254119 ↗
• MalfunctionApr 30, 2021False Negative Result; False Negative Result

  A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLES TESTED ON THE NEO IRIS, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT TWO (2) PATIENT SAMPLE TESTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED ONE (1) FALSE NEGATIVE RESULT FOR THE ANTI-E ANTIBODY AND ONE (1) FALSE NEGATIVE RESULT FOR THE ANTI-C ANTIBODY. ONE (1) INSTRUMENT MALFUNCTION PRODUCED INACCURATE ABO USING THE ABO FORWARD TYPING ASSAY BASED ON A HISTORICAL RESULT FOR THE PATIENT; INACCURATELY TYPING ANTI-D. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: Insufficient Information

  MAUDE report 11755593 ↗
• MalfunctionJan 31, 2021False Negative Result; False Negative Result

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT FOUR (4) PATIENT SAMPLES TESTED ON THE NEO IRIS, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. FOUR (4) INSTRUMENT MALFUNCTIONS PRODUCED INACCURATE ABO USING THE ABO FORWARD TYPING ASSAY BASED ON HISTORICAL RESULTS FOR THE PATIENTS; WITH ONE SAMPLE INACCURATELY RECOGNIZING ANTI-A, TWO SAMPLES INACCURATELY RECOGNIZING ANTI-B AND ONE SAMPLE INACCURATELY RECOGNIZING ANTI-D. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: Insufficient Information

  MAUDE report 11256475 ↗
• MalfunctionOct 24, 2020False Negative Result; False Negative Result

  THIS REPORT SUMMARIZES <NOE> 10 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT TEN (10) PATIENT SAMPLES TESTED ON THE NEO IRIS, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT FIVE (5) PATIENT SAMPLE TESTS USING THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED FALSE NEGATIVE RESULT FOR THE ANTI-E ANTIBODY; THREE (3) FOR THE ANTI-C ANTIBODY; ONE (1) FOR THE ANTI-FYA ANTIBODY; FOUR (4) FOR THE ANTI-S ANTIBODY; ONE (1) FOR THE ANTI-JKA ANTIBODY; ONE (1) FOR THE ANTI-CW ANTIBODY AND ONE (1) FOR THE ANTI-FYB ANTIBODY. TWO (2) INSTRUMENT MALFUNCTIONS PRODUCED INACCURATE ABO USING THE ABO FORWARD TYPING ASSAY BASED ON HISTORICAL RESULTS FOR THE PATIENTS. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731831 ↗
• MalfunctionApr 30, 2020False Negative Result; False Positive Result; Non Reproducible Results; False Negative Result; False Positive Result; Non Reproducible Results

  THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED NEGATIVE RESULT FOR ANTI-E. THE RESULT REPRESENTED A FALSE NEGATIVE DUE TO PRIOR PATIENT HISTORY OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODY. A REVIEW OF FOUR (4) PATIENT SAMPLE EVENTS ON THE NEO IRIS INDICATED UNEXPECTED ABO/RH PHENOTYPE RESULTS DURING FORWARD TESTING VERSUS PRIOR TEST RESULTS OR, TUBE/GEL TEST RESULTS COVERING ANTI-D, WEAK D AND ANTI-B. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10016369 ↗
• MalfunctionJan 29, 2020False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT 2 PATIENT SAMPLES TESTED ON THE NEO IRIS AUTOMATED BLOOD BANK SYSTEM PRODUCED UNEXPECTED ABO/RH OR ABO CROSSMATCH PHENOTYPE RESULTS VERSUS PRIOR TEST RESULTS OR, CUSTOMER TUBE/GEL TEST RESULTS. 1 PATIENT'S CROSSMATCH TEST ON THE NEO IRIS RESULTED AS COMPATIBLE AND SHOULD HAVE BEEN INCOMPATIBLE. THE CUSTOMER OF NEO IRIS MADE A TEST TO VALIDATE CROSSMATCH AND SCREENING AND THEY HAD ISSUES WITH 2 SAMPLES 1 INSTRUMENT PRODUCED TWO INCORRECT ABO/RH MISTYPE RESULTS WITH FORWARD TESTING. BOTH PATIENTS WERE TYPES AS AB+. SUBSEQUENT TESTING ON THE SAME INSTRUMENT PRODUCED ACCURATE RESULTS AS A+ AND B+. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: Test Result

  MAUDE report 9645148 ↗