Alinity 08P1021Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740136581), received between May 20, 2022 and Jan 3, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I HBSAG QUALITATIVE II RESULT FOR A PATIENT IN THE DIALYSIS UNIT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT A WEEK AGO = NEGATIVE, HEP B VACCINE ADMINISTERED. (B)(6) 2023 SAME PATIENT, NEW SAMPLE. RESULT = POSITIVE FOR BOTH HEP B ANTIGEN AND ANTIBODY. SAMPLE ID (B)(6) INITIAL RESULT = REACTIVE. REPEAT IN DUPLICATE AND BOTH RESULTS = REACTIVE. CONFIRMATORY TEST PERFORMED AND RESULT = REACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440583 ↗
• MalfunctionFeb 20, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HBSAG QUALITATIVE II AND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY RESULTS FOR A PREGNANT FEMALE PATIENT. THE SAMPLE WAS PULLED AND REPEATED 4 DAYS LATER WITH A NONREACTIVE RESULT. A SECOND SAMPLE WAS DRAWN WHICH GENERATED A NONREACTIVE RESULT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER STATED THEY HAD A SAMPLE THAT WAS DRAWN ON (B)(6) 2023 THAT RAN ON (B)(6) 2023 AND GAVE THE FOLLOWING RESULTS ACCORDING TO CUSTOMER: SID (B)(6) HBSAG=1.04 HBSAG CONFIRMATORY = REACTIVE. REPEAT OF SAMPLE ON (B)(6) 2023 SAMPLE WAS RESPUN AND RERAN IN DUPLICATE ACCORDING TO CUSTOMER: HBSAG=1.19, HBSAG=1.27, HBSAG CONFIRMATORY = 1.11 CONFIRMED POSITIVE. SAMPLE WAS RERUN ON (B)(6) 2023, RESULT = SID (B)(6) HBSAG=0.33 NONREACTIVE. NEW SAMPLE DRAWN (B)(6) 2023 SID= (B)(6) HBSAG = NONREACTIVE HBSAG CONFIRMATORY = NEGATIVE. PER ALINITY I HBSAG QUALITATIVE II PACKAGE INSERT < 1.00 NONREACTIVE NO RETEST REQUIRED. = 1.00 REACTIVE RETEST IN DUPLICATE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403034 ↗
• MalfunctionFeb 20, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HBSAG QUALITATIVE II AND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY RESULTS FOR A PREGNANT FEMALE PATIENT. THE SAMPLE WAS PULLED AND REPEATED 4 DAYS LATER WITH A NONREACTIVE RESULT. A SECOND SAMPLE WAS DRAWN WHICH GENERATED A NONREACTIVE RESULT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER STATED THEY HAD A SAMPLE THAT WAS DRAWN ON (B)(6) 2023 THAT RAN ON (B)(6) 2023 AND GAVE THE FOLLOWING RESULTS ACCORDING TO CUSTOMER: SID (B)(6) HBSAG=1.04 HBSAG CONFIRMATORY = REACTIVE. REPEAT OF SAMPLE ON (B)(6) 2023 SAMPLE WAS RESPUN AND RERAN IN DUPLICATE ACCORDING TO CUSTOMER: HBSAG=1.19 ; HBSAG=1.27 ; HBSAG CONFIRMATORY = 1.11 CONFIRMED POSITIVE. SAMPLE WAS RERUN ON (B)(6) 2023 RESULT = SID (B)(6) HBSAG=0.33 NONREACTIVE. NEW SAMPLE DRAWN (B)(6) 2023 SID= (B)(6) HBSAG = NONREACTIVE HBSAG CONFIRMATORY = NEGATIVE PER ALINITY I HBSAG QUALITATIVE II PACKAGE INSERT < 1.00 NONREACTIVE NO RETEST REQUIRED. = 1.00 REACTIVE RETEST IN DUPLICATE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16402197 ↗
• MalfunctionMay 20, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HBSAG RESULTS GENERATED ON AN ALINITY I PROCESSING MODULE FOR TWO PATIENTS THAT CONFIRMED POSITIVE AND WERE NEGATIVE ON AN OTHER METHOD. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) INITIAL RESULT = 1.35 S/CO, REPEAT RESULTS = 1.25 S/CO AND 1.33 S/CO; HBSAG CONFIRMATORY RESULTS: C1 = 0.35 S/CO, C2=1.86 S/CO, NEUT% = 94%. SAMPLE WAS SENT TO REFERENCE LAB AND CAME BACK NEGATIVE ON UNKNOWN METHODOLOGY. SID (B)(6) INITIAL RESULT = 2.63 S/CO, REPEAT RESULTS = 2.74 S/CO AND 2.72 S/CO; HBSAG CONFIRMATORY RESULTS: C2 = 2.31 S/CO, NEUT% = 97% NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458054 ↗