ORTHO 6195567Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · ORTHO® HCV Version 3.0 ELISA Test System
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750033348), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative 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.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025False Negative Result; False Negative Result
CMS (B)(4) / WINDCHILL (B)(4) ON (B)(6) 2025, A CUSTOMER CONTACTED A QUIDELORTHO QO PERSONNEL TO REPORT WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE RESULT IN HCV TESTING FOR ONE DONOR USING ORTHO HCV VERSION 3.0 ELISA TEST SYSTEM LOT SXE064 IN CONJUNCTION WITH THEIR ORTHO SUMMIT PROCESSOR 24/20 - SERIAL NUMBER (B)(6) VIP 7. DATE OF EVENT: 05 JUNE 2025 COMPLAINANT: (B)(6) - 1ST SHIFT LABORATORY OPERATIONS SUPERVISOR COMPLAINT REPORTER: (B)(6) - QO SENIOR ACCOUNT MANAGER DONOR SCREENING REPORTED ON 11 JUNE 2025 BY (B)(6) WHO REPORTED IT ON THE SAME DAY TO ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) REAGENT(S): ORTHO HCV VERSION 3.0 ELISA TEST SYSTEM LOT SXE064 EXPIRY 30 SEPTEMBER 2025 OTHER REAGENT(S): N/A SOFTWARE VERSION: NOT PROVIDED DONORS INFORMATION: SAMPLE ID: (B)(6) BACK-UP SAMPLE ID: (B)(6) THE CUSTOMER REPORTED THAT ON (B)(6) 2025, WHILE REVIEWING THE SINGLE PLATE REPORTS FOR DAY 2 OF THE PERFORMANCE QUALIFICATION (PQ) FOR THEIR VIP 26, THEY HAD IDENTIFIED A DISCREPANT NEGATIVE RESULT FOR UCN (B)(4). UCN (B)(4) WAS INITIALLY TESTED IN ROUTINE ON HCV PLATE ID (B)(4) ON (B)(6) 2025 ON VIP 7, WITH THE FOLLOWING RESULTS: - O.D. VALUE: 0.122 - S/C VALUE: 0.190 - INTERPRETATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22466319 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.