Alinity 07P5020Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380740129910), received between Oct 25, 2018 and May 23, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I ESTRADIOL RESULTS GENERATED FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025 SAMPLE ID (B)(6) = 858.93 PG/ML, (B)(6) 2025 SAMPLE WAS DILUTED AND REPEAT RESULT = 2541.91 PG/ML, REPEAT RESULT AT ANOTHER LABORATORY = 2515.97 PG/ML. SAMPLE ID (B)(6) INITIAL RESULT = 782 PG/ML, SAMPLE WAS SENT TO ANOTHER LABORATORY AND DILUTED. RESULT = 1314 PG/ML. SAMPLE ID (B)(6) INITIAL RESULT = 893 PG/ML, SAMPLE WAS SENT TO ANOTHER LABORATORY AND DILUTED. RESULT = 1259 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077605 ↗
• InjurySep 30, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I ESTRADIOL RESULTS ON A BREAST CANCER PATIENT. THE PATIENT UNDERWENT ADJUVANT TREATMENT FOR BREAST CANCER INCLUDING SUPPRESSION OF OVARIAN FUNCTION. THE LAB TESTING CONSISTENTLY GENERATED AN ESTRADIOL RESULT OF ABOUT 100 PG/ML, SUGGESTING THE TREATMENT WAS NOT EFFECTIVE. THE PATIENT UNDERWENT SURGERY TO REMOVE HER OVARIES TO ACHIEVE THE LOW ESTRADIOL LEVELS. THE MASS SPECTROMETRY ESTRADIOL LEVELS SHOWED A DISCREPANCY BETWEEN THE ALINITY I ESTRADIOL LEVELS. UPDATE: ON (B)(6) 2024, ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER STATES THAT THE FIRST TIME THE PATIENT GENERATED ESTRADIOL RESULTS WAS IN 2021. THE MOST RECENT ESTRADIOL RESULTS WERE IN 2023 ((B)(6), RUN ON (B)(6) 2023 AND (B)(6) RUN ON (B)(6) 2023). THE RESULTS WERE CONSISTENT WITH THE 2023 DATA. HOWEVER, THE CUSTOMER COULD NOT PROVIDE ACTUAL NUMERICAL VALUES FOR THESE DATES OF TESTING. THE CUSTOMER COULD NOT PROVIDE ANY FURTHER ADDITIONAL INFORMATION. THERE WAS NO FURTHER ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338131 ↗
• MalfunctionJun 15, 2023High Test Results; High Test Results

  A LITERATURE ARTICLE BY A.J. KESSLER, ET AL., ¿DISCREPANCIES IN ESTRADIOL LEVELS IN A PREMENOPAUSAL WOMAN RECEIVING ABEMACICLIB DESPITE OVARIAN FUNCTION SUPPRESSION AND BILATERAL SALPINGO-OOPHORECTOMY¿, CURRENT PROBLEMS IN CANCER: CASE REPORTS 9 (MARCH 2023), PRESENTED A CASE OF FALSELY ELEVATED ALINITY I ESTRADIOL RESULTS FOR A 44-YEAR-OLD PREMENOPAUSAL FEMALE WHO WAS DIAGNOSED WITH CLINICAL STAGE III HR+ BREAST CANCER. THE FOLLOWING INFORMATION WAS PROVIDED IN THE ARTICLE. THE PATIENT WAS TREATED WITH NEOADJUVANT DOXORUBICIN AND CYCLOPHOSPHAMIDE EVERY TWO WEEKS FOR FOUR CYCLES FOLLOWED BY PACLITAXEL EVERY TWO WEEKS FOR FOUR CYCLES. THE PATIENT UNDERWENT A LEFT MASTECTOMY WITH A LEFT AXILLARY LYMPH NODE DISSECTION AS WELL AS A PROPHYLACTIC RIGHT MASTECTOMY. THE PATHOLOGY REVEALED RESIDUAL INVASIVE POORLY DIFFERENTIATED DUCTAL CARCINOMA SPANNING 8 MM IN GREATEST DIMENSION IN THE BREAST TISSUE AND THREE OF TEN LYMPH NODES WITH SCATTERED FOCI OF TUMOR IN THE BACKGROUND OF TREATMENT-RELATED CHANGES. THE PATIENT BEGAN MONTHLY GOSERELIN 3.6 MG FOLLOWED BY ORAL ANASTROZOLE 1 MG DAILY ONE MONTH LATER. AFTER TWO MONTHS OF GOSERELIN, THE ALINITY I ESTRADIOL LEVEL WAS < 24 PG/ML (REFERENCE R

  Patient problems: Insufficient Information

  MAUDE report 17133935 ↗
• InjuryJul 7, 2022High Test Results; High Test Results

  THE CUSTOMER SUSPECTS THAT FALSELY ELEVATED ALINITY I ESTRADIOL RESULTS WERE GENERATED FOR A FEMALE PATIENT BORN IN 1983. REPEATABLE ELEVATED LEVELS WERE MEASURED MULTIPLE TIMES (SPECIFIC DATES AND VALUES NOT PROVIDED) FOR A PATIENT DIAGNOSED WITH MAMMARY CANCER (ESTROGEN-R +). DUE TO THE ELEVATED RESULTS, AN ADNEXECTOMY (REMOVAL OF FALLOPIAN TUBES AND OVARIES) WAS PERFORMED AS A THERAPEUTIC MEASURE ON (B)(6) 2022. THERE WAS NO SUBSEQUENT CHANGE IN ALINITY I ESTRADIOL LEVELS. TESTING PERFORMED ON (B)(6) 2022 GENERATED AN ALINITY I ESTRADIOL RESULT OF 107 PG/ML. REPEAT TESTING AT TWO OTHER SITES USING AN IMMUNOASSAY AND LC-MS/MS METHOD GENERATED NEGATIVE RESULTS (EXACT VALUES NOT PROVIDED). THE PATIENT WAS UNDER CONTINUOUS ABEMACICLIB THERAPY (WHICH IS A KNOWN INTERFERENT FOR THE ALINITY I ESTRADIOL ASSAY) DURING THE ESTRADIOL MEASUREMENTS.

  Patient problems: Insufficient Information

  MAUDE report 14949956 ↗
• MalfunctionJun 21, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I ESTRADIOL RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=29 PG/ML /PREVIOUS HISTORY IN (B)(6): 32000 PG/ML; (B)(6) 32000 PG/ML; (B)(6) = 50,000 PG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14757329 ↗
• MalfunctionJan 28, 2022Low Test Results; Low Test Results

  THE ACCOUNT QUESTIONED THE DIFFERENCE IN ALINITY I ESTRADIOL RESULTS ON A PATIENT SAMPLE PROCESSED ON 2 ALINITY I PROCESSING MODULES. THE ACCOUNT DOES NOT KNOW WHICH ANALYZER GENERATED THE CORRECT RESULTS FOR SID (B)(6), BUT THE RESULTS FROM SERIAL (B)(4) WERE REPORTED OUT OF THE LAB. ON (B)(6) 2022 SID (B)(6) (FEMALE) GENERATED: ALINITY I ESTRADIOL > 1000.00, 1469.89, 1491.87, 1438.42, 1442.22 PG/ML (SERIAL (B)(4)). ALINITY I ESTRADIOL 916.48. 928.19 PG/ML (SERIAL (B)(4)). ALINITY I ESTRADIOL <1000, 1473.60, 1424.74, 1430.25 PG/ML (SERIAL (B)(4)). HISTORICAL PATIENT VALUES: 125 PG/ML (ON (B)(6)2021), 104 PG/ML (ON (B)(6)2021), 360 PG/ML (ON (B)(6)2021), 120 PG/ML (ON (B)(6)2021), 61 PG/ML (ON (B)(6)2021), 91 PG/ML (ON (B)(6)2021). NO OTHER SPECIFIC PATIENT INFORMATION IS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389181 ↗
• InjuryJan 6, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I ESTRADIOL RESULTS FOR ONE PATIENT. THE CUSTOMER INDICATED THAT THE WRONG MEASUREMENT TOGETHER WITH OTHER DIAGNOSTIC INDICATIONS LED TO THE PATIENT RECEIVING AN OOPHORECTOMY. PER THE CUSTOMER, ¿AN OOPHORECTOMY WAS POTENTIALLY PERFORMED DUE TO THE INCREASED OUTCOME AND OTHER FACTORS¿. NO FURTHER INFORMATION HAS BEEN RECEIVED. THE ESTRADIOL MEASUREMENT TOGETHER WITH OTHER DIAGNOSTIC INDICATIONS LED TO THE PATIENT RECEIVING AN OOPHORECTOMY

  Patient problems: Insufficient Information

  MAUDE report 13174699 ↗
• MalfunctionNov 23, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I ESTRADIOL RESULT FOR TWO PATIENTS. THE FIRST PATIENT IS TAKING ONLY FSH/LH HORMONAL INJECTIONS. THE FOLLOWING RESULTS WERE PROVIDED (LAB EXPECTED RANGE 10-649 PG/ML): (B)(6) 2021 SID (B)(6) INITIAL RESULT = (B)(6) PG/ML; REPEAT RESULT ON (B)(6) 2021 = >(B)(6) PG/ML AND (B)(6) PG/ML (DILUTED). PROGESTERONE : (B)(6) NG/ML. LH : (B)(6) MIU/ML. FSH : (B)(6) MIU/ML. HISTORICAL RESULTS FOR THIS PATIENT WERE PROVIDED: (B)(6) 2021 SID (B)(6) RESULT = 300.35 PG/ML. (B)(6) 2021 SID (B)(6) RESULT = 44.83 PG/ML. (B)(6) 2021 SID (B)(6) RESULT = 406.22 PG/ML. (B)(6) 2021 SID (B)(6) RESULT = 1,367.16 PG/ML. (B)(6) 2021 SID (B)(6) RESULT = 2,904.31 PG/ML. THE CUSTOMER STATED THIS HAPPENED WITH A DIFFERENT PATIENT ON (B)(6) 2021, HOWEVER NO PATIENT INFORMATION WAS PROVIDED. INITIAL RESULT = (B)(6) PG/ML; REPEAT RESULT = (B)(6) PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860242 ↗
• MalfunctionAug 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY ESTRADIOL RESULTS WERE OBSERVED WHILE PERFORMING A PROFICIENCY STUDY. THE CUSTOMER STATED THAT SAMPLE ID (B)(6) GENERATED A RESULT OF 492 PMOL/L, THAT HAD A TARGET VALUE OF 336 PMOL/L, WHICH IS ALSO ABOVE THE UPPER LIMIT OF 454 PMOL/L. NO INFORMATION COULD BE OBTAINED FROM THE CUSTOMER AS TO IF THE SAMPLES HAD MIFEPRISTONE IN THEM. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385922 ↗
• MalfunctionAug 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBSERVING FALSELY ELEVATED ALINITY I ESTRADIOL RESULTS DURING THE PEER GROUP TEST. THE CUSTOMER STATED THAT A SAMPLE GENERATED A INITIAL RESULT OF 3410.5, WITH A RETEST VALUE OF 311.69 (TARGET VALUE WAS 201 WITH THE RANGE BEING 131-271). IT IS UNKNOWN IF MIFEPRISTONE WAS BEING TAKEN IN THIS CASE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281471 ↗
• MalfunctionAug 7, 2019Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT A FALSELY DECREASED ALINITY I ESTRADIOL RESULT OF 897 PG/ML WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED AT 7112 PG/ML. THE INITIAL LOW RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY AND WAS QUESTIONED WHICH PROMPTED THE RETESTING OF THE SAMPLE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8869882 ↗
• MalfunctionOct 25, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE RESULTS WHILE USING ALINITY I ESTRADIOL REAGENTS. THE FOLLOWING DATA WAS PROVIDED. AUTOMATIC DILUTION 1:5 1688, 1592 PG/ML. REPEAT (MANUAL DILUTION 1:5 USING CALIBRATOR A MATERIAL) 2720 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8007519 ↗