Alinity 06P0761Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740203672), received between Apr 28, 2026 and Apr 28, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR MULTIPLE DONOR SAMPLES THAT WERE NEGATIVE FOR THE NAT TESTING. THE FOLLOWING INFORMATION WAS PROVIDED. THE CUTOFF IS 1.00 S/CO. SID (B)(6); INITIAL RESULT = 3.44 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6); INITIAL RESULT = 2.10 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6) ; INITIAL RESULT = 3.15 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6); INITIAL RESULT = 2.65 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6) ; INITIAL RESULT = 2.38 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6): INITIAL RESULT = 2.71 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020764 ↗