Alinity 07P5131Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740160623), received between Jul 30, 2019 and Apr 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR AN 18-YEAR-OLD FEMALE. THE DOCTOR QUESTIONED THE POSITIVE RESULT. THE ORIGINAL SAMPLE WAS REPEATED AND WAS NEGATIVE. THE PATIENT WAS RECOLLECTED, AND THE SECOND SAMPLE WAS ALSO NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: ORIGINAL SAMPLE SID (B)(6): INITIAL RESULT = 103.8 MIU/ML. SID (B)(6) (SAME PATIENT/SAME SAMPLE): REPEAT RESULT = < 2.42 MIU/ML. SECOND SAMPLE COLLECTED: SID (B)(6): INITIAL RESULT = < 2.42 MIU/ML. NORMAL RANGE: <5 MIU/ML = NEGATIVE, 5 - 25 MIU/ML = INDETERMINATE (GRAYZONE), >25 MIU/ML = POSITIVE. ALL LEVELS OF QC WERE WITHIN RANGE. CUSTOMER VERIFIED THERE WAS NO FIBRIN IN THE SERUM SAMPLE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855801 ↗
• MalfunctionOct 12, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR A 19-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE B-HCG: </= 5.00 MIU/ML IS NEGATIVE, > 5.00 AND < 25.00 MIU/ML IS GRAYZONE, >/= 25.00 MIU/ML IS POSITIVE): SID (B)(6): ON (B)(6) 2023 INITIAL B-HCG = 1204 MIU/ML (POSITIVE); ON (B)(6) 2023 POINT OF CARE URINE TEST = NEGATIVE; ON (B)(6) 2023 ORIGINAL SAMPLE REPEATED = 4 MIU/ML (NEGATIVE); PREVIOUS HISTORICAL RESULT GENERATED ON (B)(6) 2023 WAS 44 MIU/ML (POSITIVE). ON (B)(6) 2023, THE CUSTOMER PROVIDED ANOTHER CASE OF A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR A PATIENT SAMPLE. THE SAMPLE ID (B)(6) GENERATED AN INITIAL HCG RESULT OF 339 MIU/ML; REPEAT RESULT GENERATED A VALUE OF < 1.20 MIU/ML. THE CUSTOMER STATED BOTH PATIENTS WERE ALMOST TREATED WITH METHOTREXATE BECAUSE DOCTORS INITIALLY SUSPECTED ECTOPIC PREGNANCY DUE TO INITIAL DISCREPANT RESULT. THE CUSTOMER CONFIRMED THE DOCTORS DID NOT TREAT THE PATIENTS SINCE REPEAT RESULTS WERE NEGATIVE. THERE WAS NO HARM TO THE PATIENTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928006 ↗
• MalfunctionMar 7, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I TOTAL -HCG RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023, SID: (B)(6) INITIAL RESULT = 43.26 IU/L (POSITIVE) WHICH WAS QUESTIONED BY THE PHYSICIAN THE SAMPLE WAS REPEATED WITH A 1:15 DILUTION AND GENERATED A RESULT OF 7000 IU/L A NEW SAMPLE WAS DRAWN (SID: (B)(6) AND GENERATED A NEGATIVE RESULT. THE ORIGINAL SAMPLE WAS REPEATED ON ANOTHER ALINITY AND GENERATED A NEGATIVE RESULT OF 2.42 IU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499117 ↗
• 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 15086727 ↗
• MalfunctionJul 30, 2019False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS OF 228 IU/L AND 221 IU/L WERE GENERATED FOR TWO DIFFERENT PATIENT SAMPLES (SIDS (B)(6)) THAT RETESTED NEGATIVE AT <2.0 IU/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841733 ↗