Galileo Neo 0064599Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10888234001041), received between Apr 20, 2016 and Oct 31, 2025 — classified as 65 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (49 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A REVIEW OF QUARTERLY EVENTS INDICATED TWO (2) EVENTS USING THE GALILEO NEO V2.0 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 23442463 ↗
• MalfunctionJul 31, 2023False Positive Result; False Positive Result

  A REVIEW INDICATED THAT ONE (1) DONOR SAMPLE TEST USING THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM MALFUNCTIONED, RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS. A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR ABO PHENOTYPING IN ONE (1) INSTANCE (INVOLVING 1 DONOR SAMPLES). A DONOR SAMPLE (FROM A PACKED RED BLOOD CELL UNIT) UNEXPECTEDLY RESULTED B-POSITIVE WITH FORWARD GROUP TESTING ON GALILEO NEO INSTRUMENT SERIAL NUMBER (B)(6). REPEAT TESTING ON THE SAME INSTRUMENT (WITH THE SAME REAGENTS), AND MANUAL TESTING BOTH RESULTED O-POSITIVE AS EXPECTED. ISSUE WAS RESOLVED AFTER SERVICE BY AN IMMUCOR FIELD SERVICE ENGINEER (FSE). FSE FOUND IMBALANCE SPRING ON CENTRIFUGE BROKEN AND PROACTIVELY REPLACED PROBE, SYRINGE, AND 3-WAY VALVE ON PROBE #3 DUE TO DISCOLORATION. NO ADVERSE EVENT OCCURRED. NO INCOMPATIBLE BLOOD PRODUCTS WERE TRANSFUSED. THE IMMUCOR INTERNAL REFERENCE FOR THE ASSOCIATED RECORD IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431210 ↗
• MalfunctionJul 26, 2023False Positive Result; False Positive Result

  A REVIEW INDICATED THAT ONE (1) DONOR SAMPLE TEST USING THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM MALFUNCTIONED, RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS. A REVIEW OF QUARTERLY EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR ABO PHENOTYPING IN ONE (1) INSTANCE (INVOLVING 1 DONOR SAMPLES). A DONOR SAMPLE (FROM A PACKED RED BLOOD CELL UNIT) UNEXPECTEDLY RESULTED B-POSITIVE WITH FORWARD GROUP TESTING ON GALILEO NEO INSTRUMENT SERIAL NUMBER (B)(6) REPEAT TESTING ON THE SAME INSTRUMENT (WITH THE SAME REAGENTS), AND MANUAL TESTING BOTH RESULTED O-POSITIVE AS EXPECTED. ISSUE WAS RESOLVED AFTER SERVICE BY AN IMMUCOR FIELD SERVICE ENGINEER (FSE). FSE FOUND IMBALANCE SPRING ON CENTRIFUGE BROKEN AND PROACTIVELY REPLACED PROBE, SYRINGE, AND 3-WAY VALVE ON PROBE #3 DUE TO DISCOLORATION. NO ADVERSE EVENT OCCURRED. NO INCOMPATIBLE BLOOD PRODUCTS WERE TRANSFUSED. THE IMMUCOR INTERNAL REFERENCE FOR THE ASSOCIATED RECORD IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401976 ↗
• MalfunctionApr 28, 2023False Negative Result; False Negative Result

  A REVIEW OF QUARTERLY EVENTS INDICATED THAT SAMPLES TESTED ON THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR KNOWN ANTIBODIES IN ONE (1) COMPLAINT INSTANCE (INVOLVING 2 PATIENT SAMPLES). A CUSTOMER REPORTED A MISSED ANTI-E AND ANTI-JKA WITH CAPTURE-R READY-SCREEN I,II (LOT NUMBER X550, EXPIRY MAY 9, 2023)AND CAPTURE-R READY-SCREEN 3 (LOT NUMBER R451, EXPIRY APRIL 9, 2023) FOR TWO PATIENT SAMPLES ON GALILEO NEO INSTRUMENT SERIAL NUMBER (B)(6) (DURING A CORRELATION STUDY; CUSTOMER WAS PERFORMING CORRELATION STUDIES BETWEEN THE 2 CELL AND 3 CELL ASSAY AS WELL AS THE LUMENA AND THE NEO). NO ADVERSE EVENT OCCURRED. NO INCOMPATIBLE BLOOD PRODUCTS WERE TRANSFUSED. AN IMMUCOR FIELD SERVICE ENGINEER REPLACED PIPETTOR #4 AND ADJUSTED RESIDUAL VOLUME FROM 0.31G TO 0.54G, AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16840006 ↗
• MalfunctionJan 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLES TESTED ON THE GALILEO NEO, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE ABORH RESULTS. IN TWO (2) TESTS, THE INSTRUMENT INCORRECTLY PRODUCED A NEGATIVE RESULT FOR ANTI-A. IN A THIRD TEST, THE INSTRUMENT'S PIPETTOR DID NOT ALLOW FOR A TEST RESULT THAT WAS ACCURATE. WITH ONE MISTYPE, ITS IS LIKELY THE MALFUNCTION WAS CAUSED BY A CUSTOMER'S ERROR; HOWEVER OUR ANALYSIS OF CUSTOMER ERROR COULD NOT BE FULLY VERIFIED. WITH THE SECOND MISTYPE; AN INSTRUMENT PIPETTOR ERROR RENDERED THE INSTRUMENT AS INTERMITTENTLY INOPERABLE. FOR THE THIRD MISTYPE, THE RESULT ON THE GALILEO NEO INSTRUMENT TYPED AB+ AGAINST B+ IN TUBE. THE PRODUCT INVESTIGATION LAB PERFORMED ABORH TESTS ON FIVE (5) KNOWN ABORH TYPED IN HOUSE DONOR SAMPLES ON THE GALILEO NEO USING RETENTION ANTI-A SER1 LOT 101055E. CONTROLS PERFORMED AS EXPECTED AND ALL IN HOUSE SAMPLES RESULTED AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. 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 CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275236 ↗
• MalfunctionOct 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLES TESTED ON THE GALILEO NEO, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE ABORH RESULTS. IN TWO (2) TESTS, THE INSTRUMENT INCORRECTLY PRODUCED A NEGATIVE RESULT FOR ANTI-D. IN A THIRD TEST; AN A POSITIVE CORD BLOOD SAMPLE MISTYPED AS AB POSITIVE. 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 SCREENING AND THE MALFUNCTIONS ARE ALLOCATED AGAINST THE ANALYTICAL INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705133 ↗
• MalfunctionJul 30, 2021False Negative Result; False Negative Result

  A REVIEW OF THE EVENTS INDICATED THAT SIX PATIENT SAMPLES TESTED ON THE GALILEO NEO, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT FOUR PATIENT SAMPLE TESTS USING THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED FALSE NEGATIVE RESULT WITH ONE FALSE NEGATIVE RESULT FOR THE ANTI-E ANTIBODY; ONE FALSE NEGATIVE RESULT FOR THE ANTI-JKB ANTIBODY; AND TWO FALSE NEGATIVE RESULTS FOR THE ANTI-K ANTIBODY. TWO INSTRUMENT MALFUNCTIONS PRODUCED INACCURATE ABO RH RESULTS BASED ON HISTORICAL INFORMATION FOR THE PATIENTS USING THE ABO FORWARD TYPING ASSAY; EACH WITH INACCURATE RESULTS FOR 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 12254114 ↗
• MalfunctionMay 12, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN WITH CAPTURE-R READY-SCREEN (I AND II) LOT NUMBER X522 ON GALILEO NEO SERIAL NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814943 ↗
• MalfunctionJan 31, 2021False Negative Result; False Negative Result

  THIS REPORT SUMMARIZES <NOE> 9 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT NINE (9) PATIENT SAMPLES TESTED ON THE GALILEO NEO, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT FOUR (4) PATIENT SAMPLE TESTS USING THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED FALSE NEGATIVE RESULT FOR THE ANTI-K ANTIBODY; TWO (2) FOR THE ANTI-JKA ANTIBODY; ONE (1) FOR THE ANTI-JKB ANTIBODY; ONE (1) FOR THE ANTI-FYA ANTIBODY; ONE (1) FOR THE ANTI-E. 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 11256454 ↗
• MalfunctionOct 24, 2020False Negative Result; False Negative Result

  THIS REPORT SUMMARIZES <NOE> 16 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT FOURTEEN (14) PATIENT SAMPLES TESTED ON THE GALILEO NEO, AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT THREE (3) PATIENT SAMPLE TESTS USING THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED FALSE NEGATIVE RESULT FOR THE ANTI-E ANTIBODY; ONE (1) FOR THE ANTI-C ANTIBODY; ONE (1) FOR THE ANTI-C ANTIBODY; ONE (1) FOR THE ANTI-JKA ANTIBODY; ONE (1) FOR THE ANTI-JKB ANTIBODY; TWO (2) FOR THE ANTI-K ANTIBODY; ONE (1) FOR THE ANTI-S ANTIBODY AND ONE (1) FOR THE ANTI-M ANTIBODY AND ONE (1) FOR ANTI-D ANTIBODY. FOUR (4) 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 10731832 ↗
• MalfunctionJul 30, 2020False Negative Result; False Positive Result; Non Reproducible Results; False Negative Result; False Positive Result; Non Reproducible Results

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLES TESTED ON THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED A DIFFERENT ABO/RH PHENOTYPE RESULT AND TWO FALSE NEGATIVE RESULTS FOR ANTIBODIES VERSUS PREVIOUS OR EXPECTED RESULTS, UTILIZING FORWARD ABO ASSAYS AND THE CAPTURE-R READY ID ASSAY. ONE PATIENT SAMPLE ON THE GALILEO NEO PRODUCED A FALSE NEGATIVE FOR ANTI-K ANTIBODY. ONE PATIENT TEST PRODUCED A FALSE NEGATIVE FOR THE ANTI-JKA ANTIBODY. A THIRD PATIENT'S TEST EXPERIENCED AN INSTRUMENT MALFUNCTION THAT LED TO AN ABO MISTYPE. 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 10345963 ↗
• MalfunctionApr 30, 2020False Negative Result; False Positive Result; Non Reproducible Results; False Negative Result; False Positive Result; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLES TESTED ON THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED UNEXPECTED ABO/RH OR ABO CROSSMATCH PHENOTYPE RESULTS VERSUS PRIOR TEST RESULTS OR, SUBSEQUENT MANUAL TUBE/GEL TEST RESULTS. ONE (1) PATIENT'S CROSSMATCH TEST ON THE GALILEO NEO RESULTED AS COMPATIBLE AND SHOULD HAVE BEEN INCOMPATIBLE, GIVEN THE PATIENT'S SAMPLE WAS ANTI-C AND THE DONOR SAMPLE WAS C+. ONE (1) TEST PRODUCED AN ABO/RH FORWARD TESTING MISTYPE RESULT DUE TO A FALSE POSITIVE RESULT OF B POSITIVE; WHEREBY HISTORICAL RESULTS DETERMINED A PHENOTYPE OF AB POSITIVE. ONE (1) GALILEO NEO RESULT WAS INCORRECT WITH A B+ RESULT INSTEAD OF AN AB+ RESULT. THE GALILEO NEO RESULTED THE DONOR AS B POSITIVE. THE DONOR BLOOD WAS RETESTED IN A REFERENCE LAB AND RESULTED AS AB POSITIVE. THE DONOR BLOOD WAS NOT USED AND RETURNED AFTER TESTING BY THE REFERENCE LAB. TUBE INTERPRETATION RESULTED AS ASUBB POSITIVE, WITH AN ANTI-A RESULT OF 1+. GALILEO NEO'S OPERATION MANUAL PROVIDES LIMITATIONS WHEREBY, THE NEO CANNOT RELIABLY DETECT HEMAGGLUTINATION REACTIONS GRADED AS 1+ OR LESS IN TEST TUBE METHODOLOGY. THROU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10016362 ↗
• MalfunctionJan 29, 2020False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLES TESTED ON THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED INCORRECT ABO/RH PHENOTYPE RESULTS AND A FALSE NEGATIVE RESULT FOR AN ANTIBODY VERSUS PREVIOUS OR EXPECTED RESULTS, UTILIZING THE CAPTURE-R READY SCREEN ASSAY. ONE PATIENT SAMPLE TEST ON THE GALILEO NEO PRODUCED A FALSE NEGATIVE FOR ANTI-K. ONE PATIENT SAMPLE TEST ON THE GALILEO NEO MISSED AN ANTI-D RESULT AFTER HAVING TESTING POSITIVE IN GEL FOR ANTI-D. A THIRD PATIENT SAMPLE TEST EXPERIENCED AN INSTRUMENT MALFUNCTION THAT LED TO AN RH MISTYPE, WHEREBY THE INSTRUMENT REPORTED RH POSITIVE WHILE THE PATIENT WAS KNOWN TO BE RH NEGATIVE. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

  Patient problems: Test Result

  MAUDE report 9644760 ↗
• MalfunctionJan 8, 2020False Negative Result; False Negative Result

  ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE FOR A PHENOTYPING ASSAY ON THE GALILEO NEO INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9564566 ↗
• MalfunctionOct 29, 2019False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT TWO (2) PATIENT SAMPLES TESTED ON THE GALILEO NEO AUTOMATED BLOOD BANK SYSTEM PRODUCED DIFFERENT ABO/RH PHENOTYPE RESULTS VERSUS OTHER FACILITIES' RESULTS OR, CUSTOMER TUBE TEST RESULTS. ONE PATIENT SAMPLE ON THE GALILEO NEO RESULTED IN AN ABO PHENOTYPE OF A+ VERSUS TYPING OF AB+ REPORTED BY TWO OTHER FACILITIES WITHOUT EXPLANATION OR DETAIL REGARDING THE TWO FACILITIES. A SECOND PATIENT SAMPLE DEMONSTRATED A PHENOTYPE OF B+ ON THE GALILEO NEO WITH AN EQUIVOCAL RESULT FOR ANTI-A. THE CUSTOMER'S TUBE TEST PRODUCED A 1+ RESULT FOR ANTI-A. THE CUSTOMER REPORTED AN A SUB B RESULT DUE TO THE RESULTS FOUND IN TUBE. THE GALILEO NEO'S OPERATOR MANUAL STATES THE INSTRUMENT CANNOT BE RELIED UPON TO DEMONSTRATE HEMAGGLUTINATION FOR GRADE 1+ OR LESS FOUND IN THE TUBE METHODOLOGY. 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 9252151 ↗
• MalfunctionAug 5, 2019False Positive Result; False Positive Result

  ON (B)(6) 2019 A CUSTOMER REPORTED RH DISCREPANCIES WHEN TESTING DONOR SAMPLES ON THE GALILEO NEO INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860787 ↗
• MalfunctionMar 14, 2019False Negative Result; False Negative Result

  ON (B)(4) 2019, A CUSTOMER SITE REPORTED AN ABO MISTYPE WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422011 ↗
• MalfunctionMar 11, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019, A CUSTOMER SITE REPORTED SOME ABO AND RH (D) MISTYPES WHEN TESTED ON A GALILEO NEO INSTRUMENT, AS PART OF A SINGLE PLATE TESTING EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8408341 ↗
• MalfunctionMar 8, 2019False Negative Result; False Negative Result

  ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN ABO MISTYPE WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON 23JAN2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405760 ↗
• MalfunctionJan 17, 2019False Negative Result; False Negative Result

  ON (B)(6) 2018 A CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-SCREEN 3 ON THE GALILEO NEO INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8258062 ↗
• MalfunctionJan 14, 2019False Negative Result; False Negative Result

  ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN ABO MISTYPE WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018 AND (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8244643 ↗
• MalfunctionDec 11, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHICH WAS INVOLVED IN A TRANSFUSION REACTION INVESTIGATION.

  Patient problems: Fever

  MAUDE report 8152528 ↗
• MalfunctionDec 7, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT FROM CAPTURE-R READY ID RUN ON A NEO INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8143178 ↗
• MalfunctionOct 15, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN ABO MISTYPE WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7966149 ↗
• MalfunctionOct 8, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018, IT WAS DETERMINED THAT A REPORT FROM (B)(6) 2018 WAS DEEMED TO BE REPORTABLE. DETAILS OF THAT REPORT FOLLOW HERE. ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN ABO MISTYPE WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON 01AUG2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7943202 ↗