ORTHO 715130Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · ANTI-FYA (ANTI-DUFFY A) 1X3ML
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10758750003365), received between Aug 12, 2024 and Aug 12, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (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.
Reports received per month
Most reported problems
Device problems
- False Positive Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2024False Positive Result; False Positive Result
REPORT 2 OF 2 CMS (B)(4), WINDCHILL (B)(4) ON (B)(6) 2024, A CUSTOMER COMPLAINED TO AN ORTHO LABORATORY SPECIALIST ABOUT WHAT WAS DESCRIBED AS DISCORDANT POSITIVE FYA(FY1) TYPING RESULTS FOR TWO PATIENTS USING ORTHO ANTI-FYA(FY1) ANTI-SERUM LOT FA246A IN TUBE METHOD. COMPLAINANT: (B)(6), RED CELL REFERENCE LABORATORY MANAGER COMPLAINT REPORTER: (B)(6), ORTHO LABORATORY SPECIALIST SUPERVISOR EVENTS DATES: 10-12 JULY 2024; REPORTED ON (B)(6) 2024 BY (B)(6) WHO REPORTED IT TO ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON THE SAME DAY. REAGENTS: ORTHO ANTI-FYA(FY1) ANTI-SERUM LOT FA246A, EXPIRY DATE 18 SEPTEMBER 2025, MANUFACTURED 18 SEPTEMBER 2023 COMPETITORS POLYSPECIFIC ANTI-HUMAN GLOBULIN LOT 030712101, EXPIRY DATE 23 FEBRUARY 2025 SOFTWARE VERSION: N/A PATIENT'S INFORMATION: EDTA SAMPLES. GENOTYPE CONFIRMED AS FY(A-B-); DAT NEGATIVE; FYA ANTIGEN NEGATIVE WITH OTHER SUPPLIERS OF ANTI-FYA(FY1) REAGENTS. PATIENTS ARE LIKELY (B)(6) ; ONE WAS V+VS+, THE OTHER WAS V-VS-. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT BETWEEN (B)(6) 2024, THEY HAD TESTED 2 PATIENTS FOR FYA (FY1) ANTIGEN TYPING IN THE INDIRECT ANTIGLOBULIN TESTING (IAT) IN TUBE METHOD AND THAT THEY HAD OBTA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19962914 ↗MalfunctionAug 12, 2024False Positive Result; False Positive Result
REPORT 1 OF 2 CMS (B)(4), WINDCHILL (B)(4) ON 17 JULY 2024, A CUSTOMER COMPLAINED TO AN ORTHO LABORATORY SPECIALIST ABOUT WHAT WAS DESCRIBED AS DISCORDANT POSITIVE FYA(FY1) TYPING RESULTS FOR TWO PATIENTS USING ORTHO ANTI-FYA(FY1) ANTI-SERUM LOT FA246A IN TUBE METHOD. COMPLAINANT: (B)(6), RED CELL REFERENCE LABORATORY MANAGER COMPLAINT REPORTER: (B)(6), ORTHO LABORATORY SPECIALIST SUPERVISOR EVENTS DATES: 10-12 JULY 2024; REPORTED ON 17 JULY 2024 BY (B)(6) WHO REPORTED IT TO ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON THE SAME DAY. REAGENTS: ORTHO ANTI-FYA (FY1) ANTI-SERUM LOT FA246A, EXPIRY DATE 18 SEPTEMBER 2025, MANUFACTURED 18 SEPTEMBER 2023 COMPETITOR POLYSPECIFIC ANTI-HUMAN GLOBULIN LOT 030712101, EXPIRY DATE 23 FEBRUARY 2025 SOFTWARE VERSION: N/A PATIENTS INFORMATION: EDTA SAMPLES. GENOTYPE CONFIRMED AS FY(A-B-); DAT NEGATIVES; FYA ANTIGEN NEGATIVE WITH OTHER SUPPLIERS OF ANTI-FYA(FY1) REAGENTS. PATIENTS ARE LIKELY AFRICAN; ONE WAS V+VS+, THE OTHER WAS V-VS-. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT BETWEEN 10 AND 12 JULY 2024, THEY HAD TESTED 2 PATIENTS FOR FYA (FY1) ANTIGEN TYPING IN THE INDIRECT ANTIGLOBULIN TESTING (IAT) IN TUBE METHOD AND THAT THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19959983 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.