Alinity 04V5121Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00380740158415), received between Nov 27, 2019 and Mar 13, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “High Test Results” (24 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT WHEN COMPARED TO OTHER REFERENCE LABS USING A DIFFERENT METHOD. THE CUSTOMER OBSERVED THE RESULTS FROM THE ALINITY ARE HIGH WHILE THE RESULTS FROM THE REFERENCE LABS (B)(6) ARE IN THE NORMAL RANGE OF 0.2-1.2 MG/DL. THE CUSTOMER STATES THE DOCTOR DECLINED TO PROVIDE RESULTS FROM THE REFERENCE LABS. THE CUSTOMER REVIEWED THE PATIENT RESULTS FROM THEIR FACILITY WITH RESULTS GOING BACK TO 2017 RANGING FROM 1.3-2.6 MG/DL. CUSTOMER STATES THEY HAVE NO ISSUES WITH CAP FAILURES, CALIBRATIONS, OR QUALITY CONTROL ISSUES. THE FOLLOWING DATA WAS PROVIDED: PATIENT TOTAL BILIRUBIN RESULTS FROM ABBOTT INSTRUMENTATION AT THE (B)(6) (UNKNOWN WHICH ARE ARCHITECT OR ALINITY): (B)(6) 2023 SID (B)(6) RESULT = 2.3 MG/DL (B)(6) 2023 SID (B)(6) RESULT = 1.8 MG/DL (B)(6) 2023 SID (B)(6) RESULT = 1.9 MG/DL (B)(6) 2022 SID (B)(6) RESULT = 1.7 MG/DL (B)(6) 2022 SID(B)(6) RESULT = 1.7 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599278 ↗
• MalfunctionMar 13, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN FOR ONE PATIENT WHEN COMPARED TO OTHER REFERENCE LAB USING A DIFFERENT METHOD. THE CUSTOMER OBSERVED THE RESULTS FROM THE ALINITY ARE HIGH WHILE THE RESULTS FROM THE REFERENCE LABS (B)(6) ARE IN THE NORMAL RANGE OF 0.2-1.2 MG/DL. THE CUSTOMER STATES THE DOCTOR DECLINED TO PROVIDE RESULTS FROM THE REFERENCE LABS. THE CUSTOMER REVIEWED THE PATIENT RESULTS FROM THEIR FACILITY WITH RESULTS GOING BACK TO 2017 RANGING FROM 1.3-2.6 MG/DL. CUSTOMER STATES THEY HAVE NO ISSUES WITH CAP FAILURES, CALIBRATIONS, OR QUALITY CONTROL ISSUES. AN EXAMPLE WAS PROVIDED FROM (B)(6) 2025 RESULT WITH SID (B)(6), RESULT = 1.5 MG/DL. ADDITIONALLY, THE FOLLOWING PATIENT TOTAL BILIRUBIN RESULTS AT (B)(6): (B)(6) 2025 SID (B)(6), RESULT = 1.5 MG/DL. (B)(6) 2024 SID (B)(6) RESULT = 1.3 MG/DL. (B)(6) 2019 SID (B)(6) RESULT = 2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595463 ↗
• MalfunctionJan 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY C TOTAL BILIRUBIN RESULT FOR A 3-DAY-OLD PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON 23DEC, WAS 66.17 MMOL/L, A NEW SAMPLE WAS COLLECTED FROM THE PATIENT LATER THAT SAME DAY, AND THE RESULT WAS 249 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201204 ↗
• MalfunctionAug 1, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS ON ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 (B)(6) INITIAL=> 25 MG/DL AND 24.64 MG/DL; EGA=18.4 MG/DL; BILISTICK RESULT=17.0 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19885649 ↗
• MalfunctionJul 1, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ALINITY C TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE. THE CUSTOMER STATED THAT THEY WERE AWARE OF THE INSUFFICIENT SAMPLE VOLUMES WHEN TESTING THE TOTAL BILIRUBIN ASSAY ON INFANTS. THE SAMPLE VOLUMES WERE BELOW THE REQUIREMENTS STATED IN THE PACKAGE INSERT. THE FOLLOWING DATA WAS PROVIDED: TOTAL BILIRUBIN RESULTS: SID (B)(6) (2-MONTH-OLD); 2 SAMPLES TAKEN ON SAME DAY: 1ST RESULT =36 UMOL/L; 2ND RESULT = 187 UMOL/L SID (B)(6) (4-DAY-OLD): RESULT = 43 UMOL/L; PREVIOUS DAY RESULT = 144 UMOL/L; NEXT DAY RESULT = 143 UMOL/L SID (B)(6) (2-MONTH-OLD): RESULT = 7 UMOL/L; PREVIOUS DAY RESULT = 91 UMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652435 ↗
• MalfunctionJun 18, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ALINITY C TOTAL BILIRUBIN RESULTS FOR ONE PATIENT. A NEW SAMPLE WAS RAN AND HAD HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON(B)(6) 2024 INITIAL RESULT = 1.08 MG/DL SID (B)(6) NEW SAMPLE RESULT = 10.97 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558341 ↗
• MalfunctionJun 9, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY C TOTAL BILIRUBIN RESULTS FOR A PATIENT FROM THE NEONATAL UNIT. THE RESULTS WERE QUESTIONED BY THE CLINICIAN AND A THIRD SAMPLE WAS DRAWN FOR CONFIRMATION WHICH GENERATED A HIGHER RESULT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 AT 12:46 SID (B)(6) TOTAL BILIRUBIN RESULT (B)(6) = 25.4 UMOL/L (ICTERUS INDEX VALUE = 186) (B)(6) 2024 AT 16:35 SID (B)(6) TOTAL BILIRUBIN RESULT (B)(6)= 13.0 UMOL/L (ICTERUS INDEX VALUE = 195) (B)(6) 2024 SID (B)(6) TOTAL BILIRUBIN RESULT = 124 UMOL/L (ICTERUS INDEX VALUE = 187) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495262 ↗
• MalfunctionMay 24, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY C TOTAL BILIRUBIN RESULTS FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: 08MAY2024 SAMPLE ID (B)(6) INITIAL RESULT = <1.7 ¿MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (AC05745) = 7.40 ¿MOL/L SAMPLE ID (B)(6) INITIAL RESULT = <1.7 ¿MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (AC05745) = 12.17 ¿MOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397660 ↗
• MalfunctionFeb 6, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR FIVE NEWBORN PATIENTS. THERE WAS NO VISIBLE HEMOLYSIS FOR THE SERUM SAMPLES. THE CUSTOMER STATED THE RESULTS FROM OTHER PLATFORMS WERE LOWER. IT THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: ALINITY C TOTAL BILIRUBIN (SERUM) RESULT = 15.1 MG/DL EGA (BLOOD GAS) CAPILLARY RESULT = 12.2 MG/DL BILISTICK RESULT = 12.0 MG/DL PATIENT 2: ALINITY C TOTAL BILIRUBIN (SERUM) RESULT = 17.4 MG/DL EGA (BLOOD GAS) CAPILLARY RESULT = 13.8 MG/DL BILISTICK RESULT = N/A PATIENT 3: ALINITY C TOTAL BILIRUBIN (SERUM) RESULT = 15.6 MG/DL EGA (BLOOD GAS) CAPILLARY RESULT = 10.0 MG/DL BILISTICK RESULT = 12.7 MG/DL PATIENT 4: ALINITY C TOTAL BILIRUBIN (SERUM) RESULT = 18.1 MG/DL EGA (BLOOD GAS) CAPILLARY RESULT = 13.2 MG/DL BILISTICK RESULT = 14.5 MG/DL PATIENT 5: ALINITY C TOTAL BILIRUBIN (SERUM) RESULT = 16.7 MG/DL EGA (BLOOD GAS) CAPILLARY RESULT = 12.6 MG/DL BILISTICK RESULT = 12.9 MG/DL CUSTOMER¿S CUT OFF FOR HOSPITALIZATION = 14.0 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649195 ↗
• MalfunctionDec 7, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULT FOR ONE SAMPLE THAT WAS REPORTED OUT OF THE LABORATORY. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 159 UNOL/L, REPEAT = 12 UNOL/L, REPEATS ON A DIFFERENT INSTRUMENT = 12 UNOL/L AND 13 UNOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282265 ↗
• MalfunctionOct 9, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY C TOTAL BILIRUBIN (TBIL) RESULT FOR ONE PATIENT SAMPLE WHEN TESTED WITH SERUM AND PLASMA. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023 SID: (B)(6) (PEDIATRIC PATIENT): SERUM TBIL RESULT = 286.4 UMOL/L / EDTA PLASMA TBIL RESULT = 211.4 UMOL/L / REPEAT TBIL RESULT = 269.7 UMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895198 ↗
• MalfunctionSep 25, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS IN NEWBORNS. THE CUSTOMER STATES THAT THEY RECEIVED COMPLAINTS FROM MEDICAL CENTERS AND THE CUSTOMER IS CURRENTLY SENDING THESE SAMPLES TO THEIR PARTNER LABORATORY FOR TESTING. THE CUSTOMER PROVIDED ONE EXAMPLE: ON (B)(6) 2023: NEWBORN SAMPLE (4 DAYS OLD AT TIME OF TESTING), SID (B)(6): ALINITY TOTAL BILIRUBIN RESULT = 16.11 MG/DL. ROCHE TOTAL BILIRUBIN RESULT = 12.8 MG/DL. THE CUSTOMER STATES FOR THEIR YOUNG PATIENTS WOULD HAVE TO GO UNDER THE UV LAMP FOR SUCH HIGH VALUES OR HAVE FURTHER BLOOD DRAWS. IT IS NOT KNOWN WHETHER THIS SPECIFIC PATIENT RECEIVED UV LAMP TREATMENT OR HAD ADDITIONAL BLOOD DRAWS. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814668 ↗
• MalfunctionJul 12, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR MULTIPLE PATIENTS. ON (B)(6( 2023, THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID(B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) SAMPLE ID (B)(6) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17307457 ↗
• MalfunctionMay 31, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR MULTIPLE NEWBORN SAMPLES BETWEEN 0-7 DAYS OVER A 3-MONTH PERIOD. THE PATIENTS WERE ELEVATED TO A HIGHER-LEVEL CARE FACILITY BASED ON THE INITIAL RESULTS AND RECEIVED PHOTOTHERAPY AND IV INFUSIONS. THE HYPERBILIRUBINEMIA HAS BEEN RESOLVED FOR ALL THREE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED NORMAL REFERENCE RANGE/CRITICAL LIMITS). ADULT = REFERENCE RANGE 0.2 - 1.2 MG/DL. CORD BLOOD CRITICAL HIGH = 2.5 MG/DL. 0-1 DAYS CRITICAL HIGH = 8.1 MG/DL. 2 DAYS CRITICAL HIGH = 11.1 MG/DL. 3-30 DAYS CRITICAL HIGH = 13.6 MG/DL. >30 DAYS CRITICAL HIGH = 10.1 MG/DL. PATIENT 1: RESULTS PROVIDED: SVD (SPONTANEOUS VAGINAL DELIVERY) ON 4/9/23 AT 1511. SID: (B)(6) 4/10 AT 1529 = 11.1 MG/DL. SID: (B)(6) 4/11 = 15.1 MG/DL. SID: (B)(6) 4/12 = 20.5 MG/DL. SID: (B)(6) 4/12 = 20.7 MG/DL. SID: (B)(6) 4/12 = 21.1 MG/DL. SID: (B)(6) 4/13 = 21.2 MG/DL. SID: (B)(6) 4/13 = 19.4 MG/DL. SID: (B)(6) 4/14 =22.2 MG/DL. PATIENT 1 THE PATIENT RECEIVED ROUTINE NEWBORN CARE, RECEIVED GLUCOSE CHECKS, AND MAINTAINED NORMOGLYCEMIA WITH SUPPLEMENTAL FORMULA. THE PATIENT BEGAN PHOTOTHERAPY AT 24 HOURS OF LIFE AND HAS CONTINUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029821 ↗
• MalfunctionJan 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT ALINITY C TOTAL BILIRUBIN RESULT FOR ONE PATIENT. THE SAMPLE WAS SENT OUT TO BE TESTED ON OTHER PLATFORMS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SID (B)(6) TOTAL BILIRUBIN = 0.68 MG/DL (EXPECTED VALUE 0.2 TO 1.2 MG/DL). HITACHI TOTAL BILIRUBIN =0.32 MG/DL (EXPECTED VALUE 0.2 TO 1.2 MG/DL). TOSHIBA TOTAL BILIRUBIN = 0.07 MG/DL (EXPECTED VALUE 0.1 TO 1.2 MG/DL). BECKMAN TOTAL BILIRUBIN = 0.6 MG/DL (EXPECTED VALUE 0.3 TO 1.0 MG/DL). PATIENT¿S HISTORICAL RESULT: (B)(6) 2022 PERFORMED ON BECKMAN DXC: TOTAL BILIRUBIN = 0.33 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221563 ↗
• MalfunctionDec 20, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ALINITY C TOTAL BILIRUBIN RESULTS FOR A PATIENT SAMPLE WHEN COMPARED TO OTHER INSTRUMENT PLATFORMS. THE FOLLOWING DATA WAS PROVIDED: PATIENT RESULT ON ALINITY C: ON (B)(6) 2022 AT 19:20: TOTAL BILIRUBIN: 10.5 UMOL/L. RETEST ON (B)(6) 2022 AT 10:34: TOTAL BILIRUBIN: 10.8 UMOL/L. NORMAL RANGE: TOTAL BILIRUBIN: 3.4 - 20.5 UMOL/L. PATIENT RESULT ON DXC700: ON (B)(6) 2022 AT 9:08: TOTAL BILIRUBIN: 23.62 UMOL/L / DIRECT BILIRUBIN: 4.94 UMOL/L. NORMAL RANGE: TOTAL BILIRUBIN: < 17 UMOL/L. PATIENT RESULT ON BT450: ON (B)(6) 2022 AT 07:14: TOTAL BILIRUBIN: 22.36 UMOL/L NORMAL RANGE: TOTAL BILIRUBIN: 8.5 - 17 UMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16011601 ↗
• MalfunctionDec 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULT FOR A NEWBORN THAT WAS BORN ON (B)(6) 2022 (4 DAYS OLD AT TIME OF INCIDENT). THE FOLLOWING INFORMATION WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 205-340 UMOL/L PATIENT IS TO BE MONITORED, > 340 UMOL/L PHOTOTHERAPY AT THE HOSPITAL). ON (B)(6) 2022 THE PATIENT GENERATED A TOTAL BILIRUBIN RESULT OF 350.8 UMOL/L. FOR THIS RESULT THE LABORATORY RECOMMENDED PHOTOTHERAPY AND THEREFORE HOSPITALIZATION. THE CUSTOMER WAS UNABLE TO OBTAIN ANY FURTHER INFORMATION ABOUT THE PATIENT AND IT IS UNKNOWN IF THE PATIENT WAS ACTUALLY HOSPITALIZED AND GIVEN PHOTOTHERAPY TREATMENT. THE SAMPLE WAS TESTED USING THE ROCHE COBAS TECHNIQUE AND GENERATED A RESULT OF 270 UMOL/L. THIS RESULT DID NOT MEET THE THRESHOLD OF RECEIVING PHOTOTHERAPY BUT ¿TO BE MONITORED¿. THE CUSTOMER RECHECKED THE SAMPLE ON (B)(6) 2022 AND GENERATED A TOTAL BILIRUBIN RESULT OF > 427.5 UMOL/L ON THE ALINITY C PROCESSING MODULE. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: Hyperbilirubinemia

  MAUDE report 15953299 ↗
• MalfunctionNov 3, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULT OF 44 MMOL/L WAS GENERATED FOR A PATIENT. TESTING PERFORMED AT TWO DIFFERENT LABORATORIES GENERATED LOWER NORMAL RESULTS OF 18 AND 15 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721970 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR EIGHT PATIENTS GENERATED ON THE ALINITY C ANALYZER. THE SAMPLES WERE REPEATED ON THE ROCHE ANALYZER WHICH GENERATED NORMAL RESULTS. THE CUSTOMER THEN RAN CONTROLS ON THE ALINITY C ANALYZER, AND THE CONTROLS WERE ALSO OUT OF RANGE HIGH. THE CUSTOMER PERFORMED DAILY MAINTENANCE, REPEATED THE CONTROLS AND CONTROLS WERE BACK IN RANGE. THE CUSTOMER REPEATED THE EIGHT SAMPLES AGAIN AND THE RESULTS WERE WITHIN THE NORMAL RANGE. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR 3 PATIENTS: NORMAL RANGE 3.4 TO 20.5 UMOL/L ON (B)(6) 2022 SID (B)(6) INITIAL RESULT = 165.3 UMOL/L, REPEAT RESULT POST MAINTENANCE = 14.2 UMOL/L, ROCHE RESULT = 13.3 UMOL/L ON (B)(6) 2022 SID (B)(6) INITIAL RESULT = 177.4 UMOL/L, REPEAT RESULT POST MAINTENANCE = 4.6 UMOL/L, ROCHE RESULT = 3.2 UMOL/L ON (B)(6) 2022 (B)(6) INITIAL RESULT = 67.3 UMOL/L, REPEAT RESULT POST MAINTENANCE = 6.4 UMOL/L, ROCHE RESULT = 5.4 UMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544588 ↗
• MalfunctionJun 20, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR MULTIPLE PEDIATRIC SAMPLES. THE FOLLOWING DATA WAS PROVIDED: (B)(6). THE PHYSICIAN HAS NOTICED A GENERAL INCREASE IN TOTAL BILIRUBIN RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14748584 ↗
• MalfunctionJun 6, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ALINITY C TOTAL BILIRUBIN RESULTS ON ONE PATIENT SAMPLE THAT REPEATED NORMAL WITH SAMPLE DILUTION. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) RAN ON AC01935: INITIAL TOTAL BILIRUBIN RESULT = ERROR CODE 1040 REACTION CHECK FAILURE, REPEAT RESULT = 24 UMOL/L THE CUSTOMER THEN PERFORMED DILUTION ON THE SAMPLE AND RAN ON AC02038. RESULT ON 1:10 DILUTION =17 UMOL/L RESULT ON 1:5 DILUTION = 16 UMOL/L THE CUSTOMER RELEASED TOTAL BILIRUBIN RESULT OF 17 UMOL/L. NORMAL REFERENCE RANGE IS 5 TO 21 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601604 ↗
• MalfunctionMay 20, 2022Low Test Results; Low Test Results

  THE LITERATURE ARTICLE BY MELVILLE, ANNA AND THOMAS, SUNETHRA DEVIKA C ¿PARAPROTEIN INTERFERENCE OF AUTOMATED TOTAL BILIRUBIN MEASUREMENT¿ DOCUMENTED PARAPROTEIN INTERFERENCE IN THE ALINITY C TOTAL BILIRUBIN ASSAY. THE AUTHOR DOCUMENTED FALSELY DEPRESSED ALINITY C TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINITY C INSTRUMENT FOR A (B)(6) MALE PATIENT. THE INITIAL RESULT WAS <9 UMOL/L (REFERENCE INTERVAL 4 TO 20 UMOL/L), ALL OTHER ROUTINE RESULTS WERE NORMAL EXCEPT TOTAL PROTEIN 120 G/L (REFERENCE INTERVAL 60 TO 85 G/L), ALBUMIN 38 G/L (REFERENCE INTERVAL 39 TO 50 G/L) AND GLOBULIN 82 G/L (REFERENCE INTERVAL 23 TO 39 G/L). THE PATIENT¿S PREVIOUS RESULTS FOR BILIRUBIN WERE <9 UMOL/L ON SEVERAL OCCASIONS, HOWEVER, 12 MONTHS PRIOR THE BILIRUBIN RESULT ON ROCHE PLATFORM WAS 54 UMOL/L, OTHER RESULTS TOTAL PROTEIN 116 G/L (REFERENCE INTERVAL 66 TO 83 G/L), ALBUMIN 37 G/L AND GLOBULIN 79 G/L). ADDITIONALLY, THE FINDINGS OF THE STUDY DOCUMENTED THAT THE PRESENCE OF PARAPROTEIN CAN AFFECT THE MEASURED CONCENTRATION OF BILIRUBIN USING THE ABBOTT ALINITY ASSAY. FURTHERMORE, IGM APPEARS TO EXERT A MORE SIGNIFICANT EFFECT ON BILIRUBIN MEASUREMENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463691 ↗
• MalfunctionApr 29, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR A (B)(6) MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 6-12 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2022, WAS 23.3 MG/DL, REPEATED USING A ROCHE ASSAY WAS 12 MG/DL. THE PATIENT WAS REDRAWN, AFTER PHOTOTHERAPY, AND THE RESULT WAS 24.6 MG/DL, REPEATED AT (B)(6) LAB WAS 16.30, REPEATED AT (B)(6) LAB WAS 16.37 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250563 ↗
• MalfunctionApr 11, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) RESULT WAS (B)(6) RESULT ON A POCT ABL 90 WAS (B)(6) MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14078737 ↗
• MalfunctionApr 6, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS ON ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) TOTAL BILIRUBIN=ERROR MESSAGE 1041 UNABLE TO CALCULATE RESULT TOTAL BILIRUBIN DILUTION 1:3=29, 23, 21, 23 UMOL/L /1:2 DILUTION=22, 22, 24 AND 22 UMOL/L LABORATORY REFERENCE RANGE FOR TOTAL BILIRUBIN= NORMAL: 5 TO 21 UMOL/L; SLIGHTLY HIGH: 21 TO 40 UMOL/L; HIGH: 40 TO 257 UMOL/L; CRITICAL: 257 TO 2138 UMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024858 ↗