RESOLVE 6902319Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10758750007691), received between May 2, 2024 and Dec 2, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (3 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.

• MalfunctionDec 2, 2025False Negative Result; False Negative Result

  CMS (B)(4) A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 07NOV2025 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS IN ANTIBODY SCREEN AND IDENTIFICATION IN IAT FOR ONE PATIENT SAMPLE USING 0.8% SURGISCREEN LOT VSS683, 0.8% RESOLVE PANEL C LOT VRC341 AND ORTHO MTS ANTI-IGG GEL CARD LOT 052025001-01 ON THEIR ORTHO VISION ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6)- MEDICAL TECHNOLOGIST; (B)(4) DATE OF EVENT: (B)(6) 2025, REPORTED ON 07NOV2025 REAGENTS: 0.8% RESOLVE PANEL C LOT VRC341, EXPIRATION: 28OCT2025, MANUFACTURE: 12AUG2025 MTS ANTI-IGG GEL CARD LOT 052025001-01, EXPIRATION: 09MAR2026, MANUFACTURE: 09JUN2025 OTHER REAGENTS: 0.8% SURGISCREEN LOT VSS683, EXPIRATION: 28OCT2025 0.8% RESOLVE PANEL B LOT VRB342, EXPIRATION: 28OCT2025 PATIENT INFORMATION: PATIENT HAS PREVIOUS HISTORY OF ANTI-JKB ANTIBODY. THE CUSTOMER REPORTED THAT ON (B)(6) 2025, A SAMPLE FROM THE PATIENT WAS TESTED FOR ANTIBODY SCREENING USING 0.8% SURGISCREEN LOT VSS683 AND MTS ANTI-IGG GEL CARD LOT 052025001-01 ON THEIR ORTHO VISION ANALYZER (B)(6), AND THAT THEY HAD OBTAINED A WEAK POSITIVE REACTION WITH CELL 3 OF THE REAGENT RED CELL. THE CUSTOMER ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691251 ↗
• MalfunctionJun 18, 2025False Negative Result; False Negative Result

  CMS (B)(4) / WINDCHILL RA610113 A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE ANTIBODY IDENTIFICATION RESULT IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% RESOLVE PANEL C LOT VRC334 AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD 011325001-10 FOR ONE PATIENT IN COMBINATION WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) (SOFTWARE VERSION 5.16.0). COMPLAINANT/COMPLAINT REPORTER NAME AND POSITION: (B)(6), SENIOR TECHNOLOGIST. EVENT DATE: 22 MARCH 2025 PATIENTS INFORMATION: PATIENT KNOWN TO HAVE AN ANTI-E(RH3) ANTIBODY SAMPLE ID: (B)(6) ENCRYPTED SAMPLE ID: (B)(6) BLOOD GROUP: A RHD POSITIVE REAGENTS: 0.8% RESOLVE PANEL C LOT VRC334 (PRODUCT CODE 6902319; EXPIRY DATE 15 APRIL 2025; MANUFACTURE DATE 28 JANUARY 2025) ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD (PRODUCT CODE MTS084024; LOT 011325001-10; EXPIRY DATE 29 OCTOBER 2025; MANUFACTURE DATE 29 JANUARY 2025) OTHER REAGENTS: 0.8% SELECTOGEN (PRODUCT CODE 6902315; LOT VS691; EXPIRY DATE 15 APRIL 2025; MANUFACTURE DATE 11 FEBRUARY 2025) ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD (PRODUCT CODE MTS08

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286601 ↗
• MalfunctionJan 16, 2025False Negative Result; False Negative Result

  CMS 2677212, 2677406, AND 2677408; WINDCHILL RA608651 EMDRS REPORTED FOR EACH 0.8% RESOLVE PANEL LISTED BELOW (3 IN TOTAL RELATED TO THIS ONE PATIENT SAMPLE) A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2024 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTI-K AGAINST MULTIPLE PANEL CELLS WITH ONE PATIENT SAMPLE FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% RESOLVE PANEL A LOT: VRA472, 0.8% RESOLVE PANEL B LOT: VRB330 AND 0.8% RESOLVE PANEL C LOT: VRC330 AND MTS ANTI-IGG GEL CARD LOT: 081324001-13 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(4). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), MEDICAL TECHNOLOGIST COMPLAINANT CONTACT INFO: (B)(6); (B)(6) CUSTOMER: (B)(6); (B)(6) EVENT DATE: 13DEC2024, REPORTED 19DEC2024. REAGENTS: 0.8% RESOLVE PANEL A LOT: VRA472, EXPIRY 24DEC2024, MANUFACTURE DATE 22OCT2024 0.8% RESOLVE PANEL B LOT: VRB330, EXPIRY 24DEC2024, MANUFACTURE DATE 22OCT2024 0.8% RESOLVE PANEL C LOT: VRC330, EXPIRY 24DEC2024, MANUFACTURE DATE 08OCT2024 MTS ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS GEL CARD LOT: 081324001-13, EXPIRY 03JUN2025 SAMPLE ID: (B)(6) PATIENT HAD A HISTORIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168277 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CMS 2611389, WINDCHILL (B)(6) COMPLAINT DESCRIPTION: ON (B)(6) 2024, THE CUSTOMER CONTACTED ORTHO'S GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) REPORTING A DIRECT SPLASH EVENT AT THEIR SITE INVOLVING 0.8% RESOLVE PANEL C, LOT VRC321 POTENTIALLY CELLS 4, 5, 6 AND 7, SPLASHING DIRECTLY INTO THE EYES OF THE OPERATOR AS THE VIALS WERE BEING LOADED ONTO THE ANALYZER. THE OPERATOR WAS NOT WEARING EYE PROTECTION AT THE TIME OF THE EVENT. COMPLAINANT: (B)(6) (MEDICAL TECHNOLOGIST) (B)(6), CUSTOMER#(B)(6), (B)(6) HOSPITAL (B)(6), EVENT DATE: 08APR2024 AT APPROXIMATELY 1PM, REPORTED SAME DAY APPROXIMATELY 6P EST. PRODUCT: 0.8% RESOLVE PANEL C LOT VRC321, EXPIRY 16APR2024, MANUFACTURED 30JAN2024. CUSTOMER STATES THE OPERATOR FLUSHED THEIR EYES FOR A MINIMUM OF FIFTEEN MINUTES ACCORDING TO THE CUSTOMER'S STANDARD OPERATING PROCEDURES (SOP). OPERATOR WAS IN CONTACT WITH THEIR SAFETY OFFICER AND WAS ADMINISTERED IMMEDIATE PROPHYLAXIS MEDICATION. BLOOD WAS DRAWN AND WILL BE TESTED FOR INFECTIOUS DISEASES. OPERATOR WILL HAVE REPEAT TESTING PER THEIR SITE POLICY IN THREE WEEKS AND UNTIL SIX MONTHS HAS PASSED. CUSTOMER STATES OPERATOR'S VISION DOES NOT APPEAR TO BE IMPAIRED, AND OPERATOR IS FEELING WEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228227 ↗