Alinity 07P5030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380740129927), received between Jul 8, 2019 and Mar 11, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I ESTRADIOL RESULTS WHICH QUESTIONED BY THE PHYSICIAN ON MULTIPLE PATIENTS FROM MULTIPLE SPECIMENS. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 PATIENT 1 SID (B)(6)=9596.4 PMOL/L /REPEATED= 11705.3 PMOL/L; SECOND SPECIMEN SID (B)(6)=1872.3 PMOL/L ; THIRD SPECIMEN SID (B)(6)=13230.6 PMOL/L PATIENT 4: SID (B)(6) INITIAL= 2259.9 PMOL/L /REPEATED ON (B)(6) 2024=4361.6 PMOL/L ON (B)(6) 2024 PATIENT 2 SID (B)(6) INITIAL= 4296 PMOL/L /REPEATED=4779.5 PMOL/L; SECOND SPECIMEN ON (B)(6) 2024 SID (B)(6) INITIAL=2773.1 PMOL/L /REPEATED=8476.2 PMOL/L ON (B)(6) 2024 PATIENT 3: SID (B)(6) INITIAL=6117.8 PMOL/L /REPEATED ON (B)(6) 2024=5476.4 AND 6625.4 PMOL/L; SECOND SPECIMEN ON (B)(6) 2024 SID (B)(6) INITIAL=734.5 PMOL/L /REPEATED=1077.5 PMOL/L AND 11930.5 PMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874348 ↗
• MalfunctionSep 21, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED ALINITY I ESTRADIOL RESULT FOR A PATIENT ON THE ALINITY I PROCESSING MODULE. THE SAMPLE WAS REPEATED AFTER THE PHYSICIAN QUESTIONED THE RESULT. THE FOLLOWING DATA WAS PROVIDED FOR SID (B)(6). INITIAL RESULT =414.5 PG/ML (1522 PMOL/L) AND THE REPEAT RESULT = 4087.8 PG/ML (15008 PMOL/L). THE CUSTOMER USES A REPORTABLE RANGE: FOLLICULAR: 77-921 MID-CYCLE:140-2380 LUTEAL:77-1145 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789091 ↗
• MalfunctionJul 12, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I ESTRADIOL RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON 22JUN2023, WAS 985, REPEAT, ON ANOTHER ANALYZER WAS >1000, REPEAT, WITH A 1:5 DILUTION, WAS 1817 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17308425 ↗
• MalfunctionApr 24, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I ESTRADIOL RESULT ON A FEMALE PATIENT. RESULTS PROVIDED: (B)(6) 2023, (B)(6) = 3017 / 3243 PG/ML (ALINITY SERIAL NUMBER (B)(6 ) (B)(6) 2023 (B)(6)= 565 PG/ML (ALINITY SERIAL NUMBER (B)(6) ) REPEATED BOTH SAMPLES ON (B)(6) 2023: (B)(6) = 3672 PG/ML; (B)(6)= >1000 / 3415 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794867 ↗
• MalfunctionSep 15, 2021Low Test Results; Low Test Results

  ON (B)(6) 2021, THE CUSTOMER PROVIDED A SECOND CASE: SID: (B)(6). INITIAL ESTRADIOL RESULT = 930 PG/ML WHICH DOES NOT CORRELATE WITH THE PATIENT¿S HISTORY. THE CUSTOMER RERAN THE SAMPLE ON ANOTHER INSTRUMENT AND GENERATED AN ESTRADIOL RESULT OF 1400 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475651 ↗
• MalfunctionJul 8, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I ESTRADIOL RESULT OF 352.5 NG/ML ON A FEMALE PATIENT THAT WAS QUESTIONED BY THE PHYSICIAN. RESULTS PROVIDED: ON (B)(6) 2019 (PATIENT STIMULATED IN VITRO) = 1259.3 PG/ML; SID (B)(6), (B)(6) 2019 = 352.5 / >1000 / 2801.2 / 2914.9 PG/ML; (B)(6) 2019 = >3000 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8768998 ↗