Alinity 07P5121Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380740160616), received between Nov 21, 2018 and Aug 4, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (11 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 21, 2018Terminated

   Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

   Z-0666-2019 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 4, 2026False Positive Result

  The customer observed positive Alinity i Total BhCG results on a patient. ID (B)(6) 2 (42 year old female) generated Alinity i Total BhCG of 59 mIU/mL (positive) on a serum sample, but the urine test was negative. The patient was tested for BhCG Roche method, BhCG Quidel-Ortho Vitros method, heterophilic antibodies, hCG tumor testing and all results were negative. Additionally, different samples from the same patient were tested with differing results. Data provided:12MAY: ID(B)(6) Alinity Result: 17 mIU/mL27MAY: ID (B)(6) Alinity Result: 21 mIU/mL29MAY: ID (B)(6) Alinity Result: 20 mIU/mL21JUN: ID (B)(6) Alinity Result: 59 mIU/mL26JUN: ID (B)(6) Alinity Result: 70 mIU/mL. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134007 ↗
• MalfunctionMar 13, 2026False Negative Result

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOTAL -HCG RESULTS FOR A 31-YEAR-OLD PREGNANT FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED NORMAL IS <5 MIU/ML) (B)(6) 2026 SID (B)(6) INITIAL RESULT = <2.42 MIU/ML, ALIQUOT OF THE SAMPLE RESULT = >30,000 MIU/ML PRIMARY TUBE REPEAT RESULT = >30,000 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593993 ↗
• MalfunctionJan 7, 2026False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I TOTAL -HCG RESULTS FOR ONE 23 YEAR OLD FEMALE PATIENT ON THE ALINITY I SERIAL NUMBER (B)(6). THE SAMPLE WAS REPEATED WITH HIGHER RESULTS(POSITIVE). THE PATIENT'S URINE PREGNANCY TEST WAS POSITIVE. THE FOLLOWING DATA WAS PROVIDED: PROCESSED ON (B)(6) 2026 SID (B)(6) INITIAL RESULT = <2.42 MIU/ML REPEAT RESULT = 24329.62 MIU/ML, REPEATED ON ANOTHER ALINITY (SERIAL NUMBER (B)(6)) = 25826.98. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995735 ↗
• MalfunctionDec 2, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL B-HCG RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED: SAMPLE 1 INITIAL ALINITY I TOTAL B-HCG RESULT WAS 198, RERUN WAS NEGATIVE. SAMPLE 2 INITIAL ALINITY I TOTAL B-HCG RESULT WAS 48, RERUN WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824566 ↗
• MalfunctionJul 17, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I TOTAL B-HCG FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 5 - 24.99 MIU/ML): SID (B)(6), (B)(6) 2024, INITIAL RESULT= 26.2 MIU/ML; REPEAT RESULT= <2 MIU/ML RESULTS WERE CONFIRMED ON THE OTHER ANALYZER. UPDATE: ADDITIONAL INFORMATION WAS PROVIDED ON 02SEPT2024. SID (B)(6), (B)(6) 2024, INITIAL B-HCG RESULT= 8.50 MIU/ML; REPEAT RESULT <2.42 MIU/ML. SID (B)(6), (B)(6) 2024, INITIAL B-HCG RESULT= 10.04 MIU/ML; REPEAT RESULT <2.42 MIU/ML. SID (B)(6), (B)(6) 2024, INITIAL B-HCG RESULT= 11.61 MIU/ML; REPEAT RESULT <2.42 MIU/ML. SID (B)(6), (B)(6) 2024, INITIAL B-HCG RESULT= 7.00 MIU/ML; REPEAT RESULT <2.42 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763902 ↗
• MalfunctionJan 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR A FEMALE PATIENT WHO IS BEING FOLLOWED FOR A MISCARRIAGE. THE CUSTOMER NOTICED THAT THE RESULT DID NOT MATCH THE PATIENT¿S HISTORY AND RERAN THE SAME SAMPLE. THE REPEATED RESULTS WERE NEGATIVE. THE CUSTOMER NOTIFIED THE PHYSICIAN AND THE RESULT WAS CORRECTED. TO ENSURE THE CORRECT RESULT FOR THE PATIENT, THE PHYSICIAN ORDERED AN ULTRASOUND AND ANOTHER BLOOD DRAW. THE CUSTOMER STATED THE PATIENT HAS NOT HAD THE ULTRASOUND. THE PATIENT¿S NEW BLOOD SAMPLE GENERATED A NEGATIVE RESULT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6) INITIAL RESULT = 127.33 MIU/ML (POSITIVE). REPEAT RESULTS = 2.93 MIU/ML (NEGATIVE) AND 3.10 MIU/ML (NEGATIVE). (B)(6) 2023 (NEW BLOOD DRAW) RESULT = < 3 MIU/ML (NEGATIVE). PATIENT¿S PREVIOUS RESULT ( (B)(6) 2023) = 50.0 MIU/ML (POSITIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441461 ↗
• MalfunctionOct 20, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS WHICH QUESTIONED BY THE PROVIDER ON ONE PATIENT. THE ONE RESULT PROVIDED WERE: SID (B)(6)INITIAL= 121.36 MIU/ML (> 25.0 IU/L=POSITIVE) /REPEATED ON ANOTHER ALINITY ANALYZER=< 2.4 MIU/ML (< OR =5.0 MIU/ML=NEGATIVE) /REPEATED ON SAME ANALYZER AI22106=< 2.4 MIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17979729 ↗
• MalfunctionSep 29, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I TOTAL -HCG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT WAS POSITIVE WHICH WAS REPORTED TO THE PHYSICIAN. THE REPEAT RESULT OF THE SAMPLE WAS NEGATIVE. THE CORRECTED RESULT WAS THEN REPORTED TO THE MEDICAL PROVIDER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506663 ↗
• MalfunctionJul 22, 2022False Positive Result; False Positive Result

  THE ACCOUNT GENERATED FALSE POSITIVE ALINITY I TOTAL BHCG RESULTS ON A PRESURGICAL PATIENT SAMPLE FOR HYSTERECTOMY. ON (B)(6) 2022, SID (B)(6) (71 YEAR OLD FEMALE, NON-HISPANIC/LATINO, RACE NOT PROVIDED) GENERATED ALINITY I TOTAL BHCG POSITIVE OF 115.90, 114.31 MIU/ML AND ON ALTERNATE ALINITY ANALYZER (SERIAL (B)(4) POSITIVE OF 133.21 MIU/ML. THE PATIENT TESTED VITROS HCG NEGATIVE <3 MIU/ML AND CARDINAL QUAL HCG COMBO URINE NEGATIVE. THE ACCOUNT STATED THERE WAS NO ADVERSE IMPACT TO PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15086406 ↗
• MalfunctionMay 11, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT ON A PATIENT. RESULTS PROVIDED: ON (B)(6) 2022 SID (B)(6) GENERATED A RESULT OF 28.52 IU/L BUT REPEATED AT < 2.42 IU/L, < 2.4 IU/L (ON ANOTHER ANALYZER). THE PATIENT WAS PREVIOUSLY NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14359119 ↗
• MalfunctionMar 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT ON A (B)(6) FEMALE PATIENT. RESULTS PROVIDED: (B)(6) 2022 SID (B)(6) = (B)(6) MIU/ML, REPEATED ON ANOTHER ALINITY AT THIS SITE = (B)(6) MIU/ML, BECKMAN DXL = < 0.2, ALERE HCG COMBO IS NEGATIVE; HETEROPHILIC AB TESTING IS NEGATIVE. THIS PATIENT HAS BEEN POSITIVE WITH THE ALINITY I TOTAL B-HCG IN THE PAST, RESULTS PROVIDED: RESULTS FROM SN# (B)(4). SID (B)(6) ; VALUE (B)(6); DATE ((B)(6) 2022). SID (B)(6) ; VALUE (B)(6); DATE ((B)(6) 2022). SID (B)(6) ; VALUE (B)(6); DATE ((B)(6) 2022). SID (B)(6) ; VALUE (B)(6); DATE ((B)(6 )2022). SID (B)(6) ; VALUE (B)(6); DATE ((B)(6) 2022). SID (B)(6) ; VALUE (B)(6); DATE ((B)(6) 2022). ANOTHER HOSPITAL = (B)(6); (ANOTHER LAB: BECKMAN DXI < 2.0 ). RESULTS FROM SN# (B)(4). SID (B)(6) ; VALUE (B)(6); DATE ((B)(6)2022). SID (B)(6) ; VALUE (B)(6); DATE ((B)(6) 2022).SID (B)(6) ; VALUE (B)(6); DATE ((B)(6) 2022). THE PATIENT HAD AN ULTRASOUND PERFORMED WITHOUT IV CONTRAST DUE TO THE POSITIVE ALINITY RESULT WHICH SHOWED NOTHING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712364 ↗
• MalfunctionMar 8, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS FOR TWO SAMPLES. THE FOLLOWING INITIAL AND REPEAT RESULTS WERE PROVIDED: (B)(6) 2022 PATIENT 1: 56.7 AND <2.4 MIU/ML ,(B)(6) 2022 PATIENT 2: 196.0 AND <2.4 MIU/ML , AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13696958 ↗
• MalfunctionNov 22, 2021False Negative Result; False Negative Result

  THE ACCOUNT STATED DISCREPANT ALINITY I TOTAL BHCG RESULTS WERE OBSERVED BETWEEN THE ALINITY I PROCESSING MODULE AND INSTRUMENT MANAGER LABORATORY INFORMATION SYSTEM (LIS). THE ACCOUNT STATED 6 PATIENT SAMPLES RESULTS OF ALINITY I TOTAL BHCG <2.42 MIU/ML WERE SENT FROM THE ALINITY I PROCESSING MODULE TO THE LIS BUT THE SAME RESULTS IN THE LIS WERE >15,000 MIU/ML. THE CORRECT PATIENT RESULTS ARE POSITIVE >15,000 MIU/ML. THROUGH TROUBLESHOOTING, IT WAS DISCOVERED THE ISSUE WAS DUE TO CONFIGURATION PARAMETERS IN ALINITY I PROCESSING MODULE. AFTER THE ADJUSTMENT OF THE CONFIGURATION PARAMETERS (LINEARITY RETEST RESULTS, CALCULATIONS FOR STANDARD DILUTIONS, REPORTABLE RANGES) THE CORRECT ALINITY I TOTAL BHCG RESULTS WERE SENT TO THE LIS. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857882 ↗
• MalfunctionOct 21, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL HCG RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (INTERPRETATION OF RESULTS: </= 5.00 MIU/ML = NEGATIVE, >/= 25.00 MIU/ML = POSITIVE, > 5.00 MIU/ML TO < 25.00 MIU/ML = GRAYZONE): (B)(6) 2021: POSITIVE HOME PREGNANCY TEST, HCG RESULT OF 155.4 MIU/ML GENERATED ON AN ARCHITECT AT A DIFFERENT LOCATION. (B)(6) 2021: HCG RESULT OF 93.2 MIU/ML GENERATED ON AN ARCHITECT AT A DIFFERENT LOCATION. (B)(6) 2021: HCG RESULT OF 32.2 MIU/ML GENERATED ON AN ARCHITECT AT A DIFFERENT LOCATION. (B)(6) 2021: HCG RESULT OF 23.4 MIU/ML GENERATED ON AN ARCHITECT AT A DIFFERENT LOCATION. (B)(6) 2021: HCG RESULT OF 25.5 MIU/ML GENERATED ON AN ARCHITECT AT A DIFFERENT LOCATION. (B)(6) 2021: HCG RESULT OF 24.4 MIU/ML GENERATED ON ALINITY (AI21152); ULTRASOUND WAS COMPLETED WHICH DID NOT DETECT AN EXTRA UTERINE PREGNANCY. (B)(6) 2021: HCG RESULT OF 32.0 MIU/ML GENERATED ON AN ARCHITECT AT A DIFFERENT LOCATION. (B)(6) 2021: PATIENT WENT UNDER A MANUAL VACUUM ASPIRATION UNDER ULTRASOUND. (B)(6) 2021: HCG RESULT OF 28.0 MIU/ML GENERATED ON AN ARCHITECT AT A DIFFERENT LOCATION. (B)(6) 2021: HCG RESULT OF 31.8 MIU/ML GENERATED ON ALINITY (AI21152); UR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675081 ↗
• MalfunctionNov 21, 2018Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use

  ABBOTT LABORATORIES HAS BECOME AWARE OF A MANUFACTURING ISSUE THAT CAN RESULT IN DAMAGE TO A BOTTLE NECK IN SOME REAGENT CARTRIDGES. IF A BOTTLE NECK IS DAMAGED, IT MAY CAUSE A FAILURE DURING THE REAGENT LOADING PROCESS ON THE ALINITY I INSTRUMENT. WHEN THE FAILURE OCCURS, ERROR CODES WILL BE GENERATED WHICH MAY LEAD TO THE POTENTIAL OF DELAYED PATIENT RESULTS. NO PATIENT INJURY HAS BEEN REPORTED DUE TO THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8097044 ↗