Alinity 07P9221Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740158316), received between Feb 5, 2023 and Dec 21, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT ERROR 1044, UNABLE TO CALCULATE RESULT. FINAL RLU READ IS OUTSIDE THE SPECIFICATION OF THE LOWEST CALIBRATOR FOR TOTAL PSA, WAS GENERATED FOR THREE PATIENT SAMPLES WHILE USING THE ALINITY I TOTAL PSA ASSAY. TWO OF THE THREE SAMPLES WERE TESTED ON A DIFFERENT ALINITY I PROCESSING MODULE AND THE SAME ERROR OCCURRED. THE CUSTOMER STATED THAT TWO OF THE PATIENTS DID HAVE VERY LOW TOTAL PSA RESULTS HISTORICALLY. THE CUSTOMER USED NEW TOTAL PSA CALIBRATOR LOT 51060FN00 TO RESOLVE THE ISSUE AND THE THREE PATIENT SAMPLES WERE RETESTED. PATIENT (B)(6) AND (B)(6): ALINITY I TOTAL PSA RESULT: <0.1 NG/ML. THE RESULTS WERE EXPECTED TO BE LOW FOR BOTH PATIENTS. NO HISTORICAL VALUES WERE PROVIDED. PATIENT (B)(6): ALINITY I TOTAL PSA RESULT: <0.1 NG/ML; ALINITY I TOTAL PSA RESULT (DIFFERENT SAMPLE TUBE): 3.86 AND 4.12 NG/ML; THE PATIENT'S LAST TOTAL PSA RESULT FROM (B)(6) 2023 WAS 7.7 NG/ML. THE CUSTOMER HAD THE PATIENT REDRAWN BECAUSE THE MEDICAL PROVIDER QUESTIONED THE LOW RESULT OF <0.1 NG/ML. THE REDRAW RESULT WAS 3.3 NG/ML. THE CUSTOMER'S REFERENCE RANGE IS 0 - 4 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376168 ↗
• MalfunctionFeb 5, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOTAL PSA RESULTS FOR ONE PATIENT THAT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT RESULTS WERE ELEVATED FROM (B)(6) 2021 THROUGH (B)(6) 2022 AND THEN SUDDENLY DROPPED (B)(6) 2022. THE RESULTS WERE STILL LOW ON (B)(6) 2023. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE WAS <4.0 NG/ML): (B)(6) 2021 RESULT WAS <3.8 NG/ML (FROM SIEMENS INSTRUMENT), (B)(6) 2021 RESULT = 6.01 NG/ML (FROM SIEMENS INSTRUMENT), (B)(6) 2022 RESULT = 5.03 NG/ML (FROM SIEMENS INSTRUMENT), (B)(6) 2022 RESULT = 5.9 NG/ML (FROM ALINITY OFF TRACK), (B)(6) 2022 RESULT = 7.8 NG/ML (FROM ALINITY OFF TRACK), (B)(6) 2022 RESULT = 2.0 NG/ML (FROM ALINITY ON TRACK), (B)(6) 2023 RESULT = 2.5 NG/ML (FROM ALINITY ON TRACK), THE CUSTOMER TRANSITIONED FROM SIEMENS INSTRUMENT TO ABBOTT¿S (ALINITY I PROCESSING MODULE) AFTER (B)(6) 2022. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT (UNKNOWN COLLECTION DATE): SID (B)(6): (GOLD TOP, MOTHER TUBE) RESULTS = 5.98 NG/ML, 6.00 NG/ML, AND 6.37 NG/ML. SID (B)(6): (ALIQUOT, FROZEN TUBE) RESULTS = 6.05 NG/ML, 6.30 NG/ML, AND 6.53 NG/ML. ADDITIONAL DATA WAS PROVIDED FOR TROUBLESHOOTING PURPOSES ONLY. THE DATA SHOWS ANOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301957 ↗