RESOLVERecalls & reported problems across all models
Ortho-Clinical Diagnostics, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 3 models of RESOLVE by Ortho-Clinical Diagnostics, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2023 and May 12, 2026 — classified as 1 injury, 37 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RESOLVE problems
Device problems
- False Negative Result36
- Adverse Event Without Identified Device or Use Problem1
- Imprecise or Erratic Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
RESOLVE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 30 reports
- 4 reports
- 4 reports
Recent RESOLVE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026False Negative Result
(B)(4) / RA614356 ON (B)(6) 2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT SAMPLE USING 0.8% RESOLVE PANEL A LOT VRA508 WITH ORTHO MTS ANTI-IGG GEL CARD LOT 120325001-05 ON THEIR ORTHO WORKSTATION ID-MTS (510012332). COMPLAINANT: (B)(6), LABORATORY TECHNOLOGIST; (B)(6) DATE OF EVENT: 14APR2026, REPORTED ON 17APR2026 REAGENTS: 0.8% RESOLVE PANEL A LOT VRA508, EXPIRATION DATE: 12MAY2026; DATE OF MANUFACTURE: 10MAR2026 MTS ANTI-IGG GEL CARD LOT 120325001-05, EXPIRATION DATE: 13OCT2026, DATE OF MANUFACTURE: 13JAN2026 OTHER REAGENTS: 0.8% RESOLVE PANEL B LOT VRB349, EXPIRATION DATE: 12MAY2026 INSTRUMENT: ORTHO WORKSTATION ID-MTS 510012332 PATIENT INFORMATION: PATIENT'S DIAGNOSIS WAS GI BLEED WITH A TRANSFUSION HISTORY OF 3 UNITS OF DONOR RBCS WITHIN THE PRIOR MONTH. ANTI-JKA ANTIBODY NEWLY IDENTIFIED; NO TITER WAS PERFORMED. SAMPLE IDS: (B)(6) (TESTED WITH PANEL A LOT VRA508) (B)(6) (TESTED WITH PANEL B LOT VRB349) (B)(6) (RE-COLLECTED SAMPLE) THE CUSTOMER REPORTED THAT ON (B)(6) 2026, A SAMPLE FROM THE PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153957 ↗MalfunctionApr 17, 2026False Negative Result
CMS 100871508 AND 100871703 / RA614115 ON (B)(6) 2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY SCREEN AND ANTIBODY IDENTIFICATION FOR ONE PATIENT SAMPLE USING 0.8% SURGISCREEN LOT VSS727 AND 0.8% RESOLVE PANEL A LOT VRA506 WITH ORTHO MTS ANTI-IGG GEL CARD LOT 110825001-12 ON THEIR ORTHO VISION SWIFT ID-MTS (50004113). COMPLAINANT: (B)(6); (B)(6); (B)(6) MEDICAL CENTER (B)(6). DATE OF EVENT: (B)(6) 2026, REPORTED ON 24-MAR-2026. REAGENTS: 0.8% SURGISCREEN LOT VSS727, EXPIRATION: 14APR2026, MANUFACTURE: 10FEB2026 0.8% RESOLVE PANEL A LOT VRA506, EXPIRATION: 14APR2026, MANUFACTURE: 10FEB2026 MTS ANTI-IGG GEL CARD LOT 110825001-12, EXPIRATION: 04SEP2026, MANUFACTURE: 04DEC2025 OTHER REAGENTS: 3% SURGISCREEN LOT 3SS792, EXPIRATION: 31MAR2026 INSTRUMENT: ORTHO VISION SWIFT ID-MTS, SN (B)(6); SW VERSION: 5.17.0 PATIENT INFORMATION: SAMPLE ID: (B)(6); ENCRYPTED SAMPLE ID: (B)(6) PATIENT HAD PREVIOUSLY IDENTIFIED ANTI-M(MNS1) ANTIBODY. PATIENT WAS NOT TRANSFUSED WITH ANY UNITS POSITIVE FOR M(MNS1) ANTIGEN. NO FURTHER INFORMATION PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6) 2026,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917107 ↗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 ↗MalfunctionApr 10, 2026False Negative Result
CMS (B)(4) / 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 ((B)(6)) 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); MEDICAL TECHNOLOGIST (B)(6) ; CORTELLUCCI (B)(6) HOSPITAL (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) P
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24840849 ↗MalfunctionJan 30, 2026False Negative Result
CMS 100686288 / RA613241 ON 08JAN2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY SCREEN AND ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT SAMPLE USING 0.8% SURGISCREEN LOT VSS701 AND 0.8% RESOLVE PANEL A LOT VRA499 WITH ORTHO MTS ANTI-IGG GEL CARD LOT 072225001-14 ON THEIR ORTHO WORKSTATION ID-MTS (510011165). COMPLAINANT: CHEN QU, MEDICAL TECHNOLOGIST; (B)(6); (B)(6) CUSTOMER(B)(6),(B)(6), (B)(6) DATE OF EVENT: (B)(6) 2026 AND (B)(6) 2026, REPORTED ON 08JAN2026 REAGENTS: 0.8% SURGISCREEN LOT VSS701, EXPIRATION: 06JAN2026, MANUFACTURE: 04NOV2025 0.8% RESOLVE PANEL A LOT VRA499, EXPIRATION: 06JAN2026, MANUFACTURE: 04NOV2025 MTS ANTI-IGG GEL CARD LOT 062525001-29, EXPIRATION: 07JUL2026, MANUFACTURE: 07OCT2025 INSTRUMENTS: ORTHO WORKSTATION ID-MTS 510011165 PATIENT INFORMATION: MALE, PREVIOUS NEGATIVE ANTIBODY SCREEN ON (B)(6) 2025 PERFORMED AT ANOTHER FACILITY. PREVIOUSLY TRANSFUSED WITH 4 DONOR RED BLOOD CELL UNITS -FROM (B)(6) 2025 TO (B)(6) 2025. RECENTLY TRANSFUSED WITH 2 DONOR RED BLOOD CELL UNITS ON(B)(6) 2026. NEWLY IDENTIFIED ANTI-JKA(JK1
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221302 ↗MalfunctionJan 20, 2026Imprecise or Erratic Results
(B)(4) / (B)(6) ON (B)(6) 2025, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT REACTIONS FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT SAMPLE USING 0.8% RESOLVE PANEL A LOT VRA500 AND ORTHO MTS ANTI-IGG GEL CARD LOT 062525001-29 ON THEIR ORTHO VISION ID-MTS ANALYZER (B)(4). COMPLAINANT/COMPLAINT REPORTER: (B)(6)- LEAD TECHNICIAN; (B)(6) CUSTOMER (B)(6). DATE OF EVENT: 26DEC2025, REPORTED ON (B)(6) 2025 REAGENTS: 0.8% RESOLVE PANEL A LOT VRA500, EXPIRATION: 20JAN2026, MANUFACTURE: 18NOV2025 OTHER REAGENTS: 0.8% SELECTOGEN LOT VS754, EXPIRATION: 20JAN2026 0.8% RESOLVE PANEL C LOT VRC344, EXPIRATION: 20JAN2026 MTS ANTI-IGG GEL CARD LOT 062525001-29, EXPIRATION: 23JUL2026 INSTRUMENTS: ORTHO VISION ID-MTS (B)(4), SW VERSION 5.16.0 ORTHO VISION ID-MTS (B)(4), SW VERSION 5.16.0 PATIENT INFORMATION: SAMPLE ID: (B)(6) ENCRYPTED ID: DC-1D-6D-41-B1-81-B5-47-B6-17-EB-5E-42-8E-E9-97-1A-BB-3A-0B-11-9D-DE-AB-24-FF-CC-83-A0-68-B0-24 THE CUSTOMER REPORTED THAT ON (B)(6) 2025, A SAMPLE FROM THE PATIENT WAS TESTED FOR ANTIBODY SCREENING USING 0.8% SELECTOGEN LOT VS754 WITH MTS ANTI-IGG CARD LOT 0625
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121735 ↗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 ↗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 ↗MalfunctionMar 14, 2025False Negative Result; False Negative Result
CMS (B)(4) WINDCHILL RA609266 A CUSTOMER CONTACTED A QUIDELORTHO ACCOUNT MANAGER ON (B)(6)2025 TO REPORT FALSE NEGATIVE ANTIBODY SCREENING AND ANTIBODY IDENTIFICATION RESULTS IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT SAMPLE HAVING AN ANTI-E(RH3) ANTIBODY USING ORTHO 0.8% SELECTOGEN LOT VS684, ORTHO 0.8% RESOLVE PANEL A LOT VRA478 AND MTS ANTI-IGG CARD LOT 111224001-05 WHILE TESTING ON AN ORTHO VISION SWIFT ID-MTS ANALYZER (SERIAL NUMBER (B)(6). COMPLAINANT NAME AND POSITION: MRS (B)(6), BLOOD BANK LEAD, (B)(6); COMPLAINT REPORTER NAME: MRS (B)(6), QUIDELORTHO ACCOUNT MANAGER (AM). REPORTED DATE: MRS (B)(6) REPORTED THE EVENTS ON 26FEB2025 TO QUIDELORTHO AM WHO REPORTED IT ON THE (B)(6) 2025 TO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) UP HEALTH SYSTEM (B)(6) (CUSTOMER NUMBER: 6344) EVENTS DATES: 20 AND 21FEB2025. REAGENTS: 0.8% RESOLVE PANEL A LOT VRA478 (EXPIRY DATE 18MAR2025, MANUFACTURED DATE 14JAN2025) 0.8% SELECTOGEN LOT VS684 (EXPIRY DATE 18MAR2025, MANUFACTURED 14JAN2025) MTS ANTI-IGG CARD LOT 111224001-05 (EXPIRY DATE 22AUG2025, MANUFACTURED 22AUG2024) OTHER REAGENTS USED BY QUIDELORTHO AM ON SITE: SELECTOGEN LOT S543 (EXPIRY DATE 04MAR2025) PATIENT INFORMATION: PAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605660 ↗MalfunctionFeb 24, 2025False Negative Result; False Negative Result
CMS (B)(4) WINDCHILL RA609036 A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6)2025 TO REPORT DISCORDANT NEGATIVE RESULTS FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% RESOLVE PANEL A LOT VRA476 EXPIRY 18FEB2025 IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOT 081324001-03 WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(6) FOR ONE PATIENT IDENTIFIED TO HAVE ANTI-E(RH3). COMPLAINANT/COMPLAINT REPORTER NAME:(B)(6), MEDICAL TECHNOLOGIST COMPLAINANT CONTACT INFO: (B)(6); (B)(6)CUSTOMER: (B)(6) EVENT DATE: 22JAN2025, REPORTED27JAN2025 REAGENTS: 0.8% RESOLVE PANEL A LOT VRA476, EXPIRY 18FEB2025, MANUFACTURE 17DEC2024 0.8% SURGISCREEN LOT VSS620, EXPIRY 18FEB2025 0.8% RESOLVE PANEL B LOT VRB332, EXPIRY 18FEB2025 MTS ANTI-IGG GEL CARD LOT 081324001-03, EXPIRY 23MAY2025 PATIENT INFORMATION: PATIENT ABORH IS B POSITIVE. PATIENT WAS LAST TRANSFUSED 1 B POSITIVE UNIT ON (B)(6)2024. SAMPLE ID: (B)(6) CUSTOMERS INDICATED ONE PATIENT SAMPLE WAS AFFECTED. THE CUSTOMER STATED THAT ON (B)(6)2025, ONE PATIENT SAMPLE WAS TESTED FOR ANTIBODY SCREEN IN INDIRECT ANTIGLOBULIN TEST (IAT) WITH 0.8% SURGISCREEN LOT VSS620 ON THEIR ORTHO VISION ID-MTS ANALY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21445031 ↗MalfunctionFeb 24, 2025False Negative Result; False Negative Result
(B)(4) WINDCHILL (B)(6) A CUSTOMER CONTACTED THE (B)(6) ON (B)(6)2025 TO REPORT DISCORDANT NEGATIVE RESULTS FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% RESOLVE PANEL A LOT VRA474 EXPIRY 21JAN2025 IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD (LOT NOT SPECIFIED) WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(6) FOR ONE PATIENT IDENTIFIED TO HAVE ANTI-E(RH3). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), MEDICAL TECHNOLOGIST COMPLAINANT CONTACT INFO: (B)(6) EVENT DATE: 13JAN2025, REPORTED (B)(6)2025 REAGENTS: 0.8% RESOLVE PANEL A LOT VRA474, EXPIRY 21JAN2025, MANUFACTURE 19NOV2024 0.8% SURGISCREEN LOT VSS613, EXPIRY 21JAN2025 0.8% RESOLVE PANEL B LOT VRB331, EXPIRY 21JAN2025 MTS ANTI-IGG GEL CARD (LOT NOT SPECIFIED) PATIENT INFORMATION: SAMPLE ID: NOT PROVIDED PATIENT HAD NO HISTORY OF ANTIBODIES CUSTOMER INDICATED ONE PATIENT SAMPLE WAS AFFECTED. THE CUSTOMER STATED THAT ON (B)(6)2025 ONE PATIENT SAMPLE WAS TESTED FOR ANTIBODY SCREEN IN INDIRECT ANTIGLOBULIN TEST (IAT) WITH 0.8% SURGISCREEN LOT VSS613 ON THE VISION ID-MTS ANALYZER AND A 2+ POSITIVE REACTION WAS OBSERVED FOR CELL 2; WHILE SUBSEQUENT ANTIBODY IDENTIFICATION TESTING IN INDIRECT ANTIGLOBULIN TEST
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21444927 ↗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 ↗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 ↗MalfunctionJan 16, 2025False Negative Result; False Negative Result
(B)(4) 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)(6). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), MEDICAL TECHNOLOGIST COMPLAINANT CONTACT INFO: (B)(6); (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) PATIENTS HAD A HISTORICAL ANTI-K, IDENTIFIED BY A REFERENCE LABORATORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21168173 ↗
Other Ortho-Clinical Diagnostics, Inc. products
All Ortho-Clinical Diagnostics, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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