RESOLVE 6902318Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10758750007684), received between Jun 26, 2024 and Apr 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Negative 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.

• MalfunctionApr 11, 2026False Negative Result

  CMS 100847098 / RA613978 ON (B)(6) 2026, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS FALSE NEGATIVE ANTIBODY SCREEN/IDENTIFICATION RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT ON THEIR ORTHO VISION SWIFT ID-MTS ANALYZERS (50003311 AND 50003312) USING 0.8% SELECTOGEN LOTS: VS767 / VS769, 0.8% RESOLVE PANEL A LOT: VRA504 AND 0.8% RESOLVE PANEL B VRB347 IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOTS: 110825001-07 / 110825001-14. COMPLAINANT: (B)(6) CUSTOMER (B)(6); (B)(6) DATES OF EVENTS: 04 AND 13MAR2026; REPORTED 16MAR2026 EQUIPMENT: ORTHO VISION ID-MTS ANALYZER SERIAL NUMBERS: (B)(6) REAGENTS: 0.8% SELECTOGEN LOT: VS767, EXPIRY 17MAR2026, MANUFACTURED 13JAN2026 0.8% SELECTOGEN LOT: VS769, EXPIRY 31MAR2026, MANUFACTURED 27JAN2026 0.8% RESOLVE PANEL A LOT: VRA504, EXPIRY 17MAR2026, MANUFACTURED 13JAN2026 0.8% RESOLVE PANEL B LOT: VRB347, EXPIRY 17MAR2026, MANUFACTURED 13JAN2026 MTS ANTI-IGG GEL CARD LOT: 110825001-07, EXPIRY 24AUG2026, MANUFACTURED 24NOV2025 MTS ANTI-IGG GEL CARD LOT: 110825001-14, EXPIRY 10SEP2026, MANUFACTURED 10DEC2025 PATIENT INFORMATION: SAMPLE IDS: (B)(6) (SAMPLE 1) AND (B)(6) (SAMPLE 2) PATIENT SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847496 ↗
• MalfunctionJun 17, 2025False Negative Result; False Negative Result

  (B)(4) ON WINDCHILL RA611170 (B)(6) 2025, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE REACTION IN ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST IAT FOR ONE PATIENT USING 0.8% RESOLVE PANEL B FOR GEL LOT VRB337 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER 50002173. DATE OF EVENT 16 MAY 2025 COMPLAINANT/COMPLAINT REPORTER: (B)(6) - LABORATORY SUPERVISOR REPORTED ON 20 MAY 2025 BY (B)(6) TO ORTHO GTSC REAGENT(S): 0.8% RESOLVE PANEL B FOR GEL LOT VRB337 EXPIRY 10 JUNE 2025, MANUFACTURED 08 APRIL 2025 MTS ANTI-IGG CARD LOT 101824001-12, EXPIRY 12 AUGUST 2025, MANUFACTURED 12 NOVEMBER 2024 OTHER REAGENT(S): 0.8% SURGISCREEN FOR GEL LOT VSS650; EXPIRY 10 JUNE 2025; MANUFACTURED 08 APRIL 2025 0.8% RESOLVE PANEL C FOR GEL LOT VRC336 EXPIRY 10 JUNE 2025, MANUFACTURED 25 MARCH 2025 0.8% RESOLVE PANEL C FOR GEL LOT VRC334 EXPIRY 15 APRIL 2025, MANUFACTURED 28 JANUARY 2025 0.8% RESOLVE PANEL B FOR GEL LOT VRB336 EXPIRY 13 MAY 2025, MANUFACTURED 11 MARCH 2025 SOFTWARE VERSION: 5.16.0 PATIENT'S INFORMATION: SAMPLE ID: 25136-LBB079 THE CUSTOMER REPORTED THAT ON (B)(6) 2025 AT 21:27, THEY HAD TESTED THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22238093 ↗
• MalfunctionJan 16, 2025False Negative Result; False Negative Result

  CMS , (B)(4); 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 (50004025). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), MEDICAL TECHNOLOGIST COMPLAINANT CONTACT INFO: (B)(6); (B)(6) MEDICAL CENTER, (B)(6) EVENT DATE: 13DEC2024, REPORTED (B)(6) 2024. 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 HISTORICAL ANTI-K, IDENTIFIED BY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168223 ↗
• MalfunctionJun 26, 2024False Negative Result; False Negative Result

  CMS 2624366, WINDCHILL RA606432 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2024 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTI-FYA AGAINST MULTIPLE PANEL CELLS WITH ONE PATIENT SAMPLE FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% RESOLVE PANEL B LOT VRB323 EXPIRY 11JUN2024 AND MTS ANTI-IGG GEL CARD LOT 072523001-05 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER ( (B)(4) ). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), MEDICAL TECHNOLOGIST COMPLAINANT CONTACT INFO: (B)(6), EVENT DATES: 23MAY2024, REPORTED 28MAY2024. REAGENTS: 0.8% RESOLVE PANEL B LOT VRB323, EXPIRY 11JUN2024, MANUFACTURE DATE: 09APR2024 0.8% RESOLVE PANEL A LOT VRA458, EXPIRY 11JUN2024, MANUFACTURE DATE: 09APR2024 MTS ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS GEL CARD LOT 072523001-05, EXPIRY 30MAY2024 SAMPLE ID: (B)(6) (ENCRYPTED: C4-C9-69-12-8A-82-42-E4-52-C5-EE-BE-9F-D7-AC-8F-65-F1-4C-12-CF-FB-92-76-8C-FA-D5-E3-14-1D-3B-97) PATIENT DID NOT HAVE AN ANTIBODY HISTORY AT THIS FACILITY. ANTI-E AND FYA WERE IDENTIFIED AT ANOTHER HOSPITAL IN THE AREA ONE MONTH PRIOR USING A COMPETITOR'S REAGENT. THE CUSTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619353 ↗