AlinityRecalls & reported problems across all models

We found 15 models of Alinity by Abbott Ireland Diagnostics in the FDA's device registry (GUDID). Together they are named in 155 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2020 and Jun 11, 2026 — classified as 104 injuries, 51 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (129 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Alinity recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 24, 2025Open, Classified

   transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

   Z-1852-2025 · Root cause: Storage · Recall details · FDA record ↗

2. Apr 24, 2023Open, Classified

   Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

   Z-1696-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Alinity problems

Alinity models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Alinity 06P0260
  117 reports
• Alinity 09P3521

  SYSTEM, TEST, THYROID AUTOANTIBODY
  1 recall0 reports
• Alinity 07P9321

  Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
  1 recall0 reports
• Alinity 09P4220

  ENZYME IMMUNOASSAY, TRACROLIMUS
  6 reports
• Alinity 07P9030

  KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
  5 reports
• Alinity 07P6220

  SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
  5 reports
• Alinity 06P0359
  5 reports
• Alinity 08P1021

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  4 reports
• Alinity 08P1121

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  3 reports
• Alinity 07P9020

  KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
  3 reports
• Alinity 07P6230

  SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
  2 reports
• Alinity 07P9221

  Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
  2 reports
• Alinity 09P4120

  Sirolimus test system
  1 report
• Alinity 07P9231

  Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
  1 report
• Alinity 04V3720

  MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
  1 report

Recent Alinity adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I MYOGLOBIN RESULTS GENERATED ON A 59YRS OLD MALE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) NEW REAGENT=131.7 NG/ML /PREVIOUS REAGENT=163.8 NG/ML. LABORATORY REFERENCE RANGE FOR MYOGLOBULIN= < 140 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473336 ↗
• MalfunctionMar 5, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY RESULTS GENERATED FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE >/= 1.0 S/CO IS REACTIVE): UNIT OF MEASURE = S/CO SAMPLE ID (B)(6) INITIAL RESULT ON AS1453 = 3.6, REPEAT RESULTS ON (B)(6) = 2.4, 2.31; SAMPLE ID (B)(6) INITIAL RESULT ON AS1473 = 3, REPEAT RESULTS ON (B)(6) = 2.56, 2.07; SAMPLE ID (B)(6) INITIAL RESULT ON AS1473 = 4.49, REPEAT RESULTS ON (B)(6) = 4.36, 4.72; SAMPLE ID (B)(6) INITIAL RESULT ON AS1473 = 2.84, REPEAT RESULTS ON (B)(6) = 2.56, 2.81; SAMPLE ID (B)(6) INITIAL RESULT ON AS1453 = 2.09, REPEAT RESULTS ON (B)(6) = 1.39, 1.35; SAMPLE ID (B)(6) INITIAL RESULT ON AS1473 = 2.99, REPEAT RESULTS ON (B)(6) = 2.71, 2.45; SAMPLE ID (B)(6) INITIAL RESULT ON AS1486 = 1.53, REPEAT RESULTS ON (B)(6) = 1.36, 1.27; SAMPLE ID (B)(6) INITIAL RESULT ON AS1486 = 1.37, REPEAT RESULTS ON (B)(6) = 1.09, 1.16; SAMPLE ID (B)(6) INITIAL RESULT ON AS1453 = 6.15, REPEAT RESULTS ON (B)(6) = 2.95, 2.93; SAMPLE ID (B)(6) INITIAL RESULT ON AS1453 = 20.97, REPEAT RESULTS ON (B)(6) = 12, 12.35; SAMPLE ID(B)(6) INITIAL RESULT ON AS1453 = 10.08, REPEAT RESULTS ON (B)(6) = 6.13, 6.06; S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518579 ↗
• MalfunctionMar 5, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY RESULTS GENERATED FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE >/= 1.0 S/CO IS REACTIVE): UNIT OF MEASURE = S/CO. SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 3.6, REPEAT RESULTS ON (B)(6) = 2.4, 2.31; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 3, REPEAT RESULTS ON (B)(6) = 2.56, 2.07; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 4.49, REPEAT RESULTS ON (B)(6) = 4.36, 4.72; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 2.84, REPEAT RESULTS ON (B)(6) = 2.56, 2.81; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 2.09, REPEAT RESULTS ON (B)(6) = 1.39, 1.35; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 2.99, REPEAT RESULTS ON (B)(6) = 2.71, 2.45; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 1.53, REPEAT RESULTS ON (B)(6) = 1.36, 1.27; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 1.37, REPEAT RESULTS ON (B)(6) = 1.09, 1.16; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 6.15, REPEAT RESULTS ON (B)(6) = 2.95, 2.93; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 20.97, REPEAT RESULTS ON (B)(6) = 12, 12.35; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 10.08, REPEAT RESULTS ON (B)(6) = 6.13, 6.06;

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518511 ↗
• MalfunctionFeb 3, 2026False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY. THE CUSTOMER REPORTED THAT THE FOLLOWING SAMPLES WERE REPEAT REACTIVE FOR ALINITY S HBSAG AND CONFIRMED WITH ALINITY S HBSAG CONFIRMATORY THE CUSTOMER REPORTED THAT FURTHER SUPPLEMENTAL TESTING WAS PERFORMED. NAT TESTING GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT TESTING OCCURRED BETWEEN (B)(6) 2025 AND PROVIDED THE FOLLOWING DATA: REFERENCE RANGE: = 1.0 S/CO IS REACTIVE SAMPLE ID (B)(6) HBSAG RESULTS WERE 3.88, 2.95 & 2.45. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULTS WERE 152.90, 148.10, & 147.71. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULT WAS 17.37. SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULT WAS 10.08, 6.13 & 6.06. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246864 ↗
• MalfunctionFeb 3, 2026False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY. THE CUSTOMER REPORTED THAT THE FOLLOWING SAMPLES WERE REPEAT REACTIVE FOR ALINITY S HBSAG AND CONFIRMED WITH ALINITY S HBSAG CONFIRMATORY THE CUSTOMER REPORTED THAT FURTHER SUPPLEMENTAL TESTING WAS PERFORMED. NAT TESTING GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT TESTING OCCURRED BETWEEN 21 AND 22 DEC 2025 AND PROVIDED THE FOLLOWING DATA: REFERENCE RANGE: = 1.0 S/CO IS REACTIVE SAMPLE ID (B)(6) HBSAG RESULTS WERE 3.88, 2.95 & 2.45. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULTS WERE 152.90, 148.10, & 147.71. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULT WAS 17.37. SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULT WAS 10.08, 6.13 & 6.06. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246861 ↗
• MalfunctionDec 9, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I AFP RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR THREE PATIENTS. NO INFORMATION WAS AVAILABLE REGARDING THE PATIENTS¿ DIAGNOSES. THE SAMPLES WERE REPEATED, AND LOWER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: =8.1 G/L. SID (B)(6) (59-YEAR-OLD MALE): (B)(6) 2025 ALINITY I AFP INITIAL RESULT = 42.4 G/L, REPEAT RESULT = 2.9 G/L. SID (B)(6) (83-YEAR-OLD FEMALE): (B)(6) 2025 ALINITY I AFP INITIAL RESULT = 23.2 G/L, REPEAT RESULT = 1.5 G/L SID (B)(6) (64- YEAR-OLD MALE): (B)(6) 2025 ALINITY I AFP INITIAL RESULT = 20.1 G/L, REPEAT RESULT = 12.6 G/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757037 ↗
• MalfunctionNov 3, 2025False Positive Result; False Positive Result

  AN ARTICLE BY SARA O. DIONNE, HILLARY C. S. R. AKANA, MICHAEL REAL, KIMBERLY A. ELLIOTT, BRENDEN R. O¿NEALE ¿INCREASED SEROLOGIC REACTIVITY WITH AUTOMATED CMIA TESTING AND ITS IMPLICATIONS FOR DECEASED DONOR ELIGIBILITY DETERMINATION IN THE UNITED STATES¿, CELL TISSUE BANK (2025) 26:40 MENTIONS REPEAT REACTIVE RESULTS FOR SAMPLES WITH ALINITY S HIV AG/AB COMBO, ALINITY S HTLV I/II, ALINITY S ANTI-HCV, ALINITY S HBSAG, AND ALINITY S ANTI-HBC. IT ALSO STATES THAT SOME SAMPLES WERE DISCREPANT TO NAT. THESE RESULTS COULD LEAD TO REJECTION OF DONATED TISSUE SAMPLES. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449354 ↗
• MalfunctionOct 29, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I AFP FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE <=8.8 UG/L): ON (B)(6) 2025, SID (B)(6), INITIAL AFP RESULT (B)(6) = 559.12 UG/L; (B)(6) 2025, ANOTHER SAMPLE WAS COLLECTED, SID (B)(6), INITIAL RESULT (B)(6) = 6.37 UG/L; (B)(6) 2025, REPEAT RESULT= 5.78 UG/L, (B)(6) 2025, REPEAT RESULT ON ANOTHER ANALYZER (B)(6 )= 5.69 UG/L. ADDITIONAL RESULTS PROVIDED: CA125 RESULT= 3.6 U/ML; CEA RESULT= 1.00 UG/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23421164 ↗
• MalfunctionAug 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I AFP RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS </=8.8 UG/L): SAMPLE ID (B)(6), INITIAL RESULT, ON (B)(6) 2025, WAS 62.65, REPEAT RESULT WAS 4.26, REPEAT RESULT, ON ANOTHER ANALYZER, WAS 3.90 UG/L. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: CEA WAS 3.8 UG/L, TPSA WAS <0.025 UG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708768 ↗
• MalfunctionJun 19, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TACROLIMUS RESULTS FOR A 57-YEAR-OLD MALE BILATERAL LUNG TRANSPLANT PATIENT. THE PATIENT¿S RESULTS FROM (B)(6) 2025 UNTIL (B)(6) 2025 RANGED FROM 4.5 TO 22.5 UG/L. ON (B)(6) 2025, THE RESULT WAS >60 UG/L AND THE PATIENT¿S TACROLIMUS THERAPY WAS DISCONTINUED FOR FIVE DAYS. ON (B)(6) 2025, RESULT WAS 58.2, ON (B)(6) THE RESULT WAS 46.4, ON (B)(6) THE RESULT WAS 32.0, AND ON (B)(6) THE RESULT WAS 29.8 UG/L. ON (B)(6) 2025 THE RESULT WAS 53.8 UG/L, AND THE SAMPLE WAS ALSO TESTED AT A DIFFERENT LABORATORY, USING A DIFFERENT METHOD, AND THE RESULT WAS <0.6 UG/L. THE PATIENT WAS THEN PRESCRIBED TACROLIMUS AGAIN. ON (B)(6), THE RESULT WAS 18.8, REPEAT RESULT, TESTED ON ANOTHER METHOD, WAS 14.2 UG/L. ON (B)(6), THE RESULT WAS 26.1, REPEAT RESULT, TESTED ON ANOTHER METHOD, WAS 18.3 UG/L. IT WAS NOTED THAT THERE WAS NO NEGATIVE IMPACT TO THE PATIENT DUE TO THE DISCONTINUANCE OF THE TACROLIMUS THERAPY. THERE WAS NO OTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293871 ↗
• MalfunctionApr 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ALINITY I AFP AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE (B)(6) INITIAL RESULT WAS 83.7 UG/LAND REPEAT RESULT ON ANOTHER ANALYZER WAS <2 UG/L. NO FURTHER PATIENT DATA WAS PROVIDED. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21819378 ↗
• MalfunctionMar 10, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I AFP RESULTS FOR ONE PATIENT. THE PATIENT WAS REPEATED ON MULTIPLE INSTRUMENTS WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: (AFP REFERENCE VALUE AT FACILITY: 0.9-8.8 NG/ML) SID (B)(6) INITIAL ALINITY AFP RESULT PROCESSED ON (B)(6) 2025 ON SERIAL NUMBER (B)(6) = 39.50 NG/ML RETESTED ON (B)(6) 2025 ON (B)(6) = <2.0 NG/ML AND ON (B)(6) = <2.00 NG/ML NEW SPECIMEN SAME PATIENT SID (B)(6) PROCESSED ON (B)(6) 2025 RESULTS FROM ALINITY I INSTRUMENT SERIAL NUMBER (B)(6) = <2.00 NG/ML AND <2.00 NG/ML AND PROCESSED ON (B)(6) = <2.0 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561728 ↗
• MalfunctionMar 3, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I AFP GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE: 0.9 - 8.8 UG/L. (B)(6): SAMPLE ID: (B)(6), (PATIENT FROM HEALTH SCREENING). 1ST RUN (B)(6): 13.4, 2ND RUN (B)(6): 2.6, 3RD RUN (B)(6): 2.6. ON (B)(6): SAMPLE ID: (B)(6), (PATIENT FROM ENT CLINIC). 1ST RUN (B)(6): 11.7, 2ND RUN (B)(6): 8.0, 3RD RUN (B)(6): 7.4. ON (B)(6): SAMPLE ID: (B)(6), (PATIENT FROM GASTROINTESTINAL CLINIC). 1ST RUN (B)(6): 26. 2ND RUN (B)(6): 2.9. 3RD RUN (B)(6): 3.3. NO OTHER PATIENT INFORMATION WAS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509097 ↗
• MalfunctionDec 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT ALINITY I TACROLIMUS RESULTS FOR A PATIENT WITH THE DATE OF BIRTH (B)(6) 2007. THE FOLLOWING RESULTS WERE PROVIDED: THE RESULTS WERE PROVIDED INCLUDED MULTIPLE SIDS FOR THE SAME PATIENT. (CUSTOMER PROVIDED TACROLIMUS REFERENCE RANGE 5-15 NG/ML) ON (B)(6) 2024, SID (B)(6) RESULT = <2.0 NG/ML. ON (B)(6) 2024 RESULT = 13.2 NG/ML, ON (B)(6) 2024 RESULT = 18.5 NG/ML, ON (B)(6) 2024 RESULT = 44.2 NG/ML, ON (B)(6) 2024 RESULT = 15.4 NG/ML, ON (B)(6) 2024 RESULT = 13.7 NG/ML, ON (B)(6)2024 RESULT = 2.9 NG/ML, ON (B)(6)2024 RESULT = 11.2 NG/ML, ON (B)(6) 2024 RESULT = 16.5 NG/ML, ON (B)(6) 2024 RESULT = 29.7 NG/ML, ON (B)(6) 2024 RESULT = 7.4 NG/ML, ON (B)(6) 2024 RESULT = 14.3 NG/ML, ON (B)(6) 2024 RESULT = 12.4 NG/ML, ON (B)(6) 2024 RESULT = 5.1 NG/ML, ON (B)(6) 2024 RESULT = 6.4 NG/ML, ON (B)(6) 2024 RESULT = 6.4 NG/ML, ON (B)(6) 2024 RESULT = 3.8 NG/ML, ON (B)(6) 2024 RESULT = 3.8 NG/ML, ON (B)(6) 2024 RESULT = 3.4 NG/ML, ON (B)(6) 2024 RESULT = 3.4 NG/ML, ON (B)(6) 2024 RESULT = 2.2 NG/ML, ON (B)(6) 2024 RESULT = 2.2 NG/ML, ON (B)(6) 2024 RESULT = 3.2 NG/ML, ON (B)(6) 2024 RESULT = 3.2 NG/ML, ON (B)(6) 2024 RESULT = <2 NG/ML, ON (B)(6) 2024 RESULT = 5.6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923553 ↗
• MalfunctionSep 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS ON 4 CADAVERIC PATIENTS. SAMPLE 3 WAS ALSO RETESTED USING A PRE-MORTEM SAMPLE WITH REACTIVE RESULTS ON THE ALINITY, NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS ON THE PRE-MORTEM SAMPLE. NAT AND BIORAD EIA WERE NEGATIVE FOR ALL SAMPLES. FURTHER TESTING ON THE ALINITY HAD MIXED REACTIVE AND NONREACTIVE RESULTS. TISSUE SAMPLES WERE DISCARDED FOR ALL 4. THE FOLLOWING DATA WAS PROVIDED (REFERENCE = 1.0 S/CO IS REACTIVE): SAMPLE 1 TESTING: ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 2.32, 2.03, 1.90, 2.10, 2.40. ON (B)(6) ,2024 SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.23, REPEAT RESULT = 0.82 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6), (EDTA SAME PATIENT AS SID(B)(6): PANTHER RESULT = NONREACTIVE. SAMPLE 2 TESTING: ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.90, 1.89, 2.17 ON (B)(6)2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.59, REPEAT RESULT = 0.89 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128647 ↗

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