RESOLVE 6902317Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10758750007677), received between Feb 1, 2023 and May 12, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (29 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 25 most recent of 30 reports, 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 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 ↗
• 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

  (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 ↗
• MalfunctionJul 2, 2024False Negative Result; False Negative Result

  CMS (B)(4) , WINDCHILL (B)(4) REPORT 1 OF 3 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2024 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS WITH CELL 3 (R2R2) OF 0.8% RESOLVE PANEL A LOT VRA459 DURING ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR TWO PATIENTS USING AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD (B)(4) IN COMBINATION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER SERIAL (B)(6) (SOFTWARE VERSION NOT PROVIDED). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), LABORATORY SUPERVISOR. EVENTS DATES: 29 AND 30 MAY 2024. PATIENT INFORMATION: PATIENT 1 KNOWN TO HAVE AN ANTI-E(RH3) ANTIBODY. ANTIBODY SCREENING POSITIVE 3+ WITH CELL 2 OF 0.8% SELECTOGEN LOT VS593, BEING E(RH3) ANTIGEN POSITIVE (HOMOZYGOUS). SAMPLE ID (B)(6) SAMPLE ID (B)(6) KNOWN TO HAVE AN ANTI-E(RH3) ANTIBODY. CUSTOMER EXPECTED POSITIVE REACTIONS WITH CELL 3 (R2R2) OF 0.8% RESOLVE PANEL A LOT VRA459. NO FURTHER INFORMATION PROVIDED. REAGENTS 0.8% RESOLVE PANEL A LOT VRA459 (PRODUCT CODE 6902317; EXPIRY DATE 25 JUNE 2024; MANUFACTURE DATE 23 APRIL 2024) ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD (B)(4

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660843 ↗
• MalfunctionJul 2, 2024False Negative Result; False Negative Result

  CMS 2626973 AND 2627044, WINDCHILL RA606690 REPORT 3 OF 3 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2024 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS WITH CELL 3 (R2R2) OF 0.8% RESOLVE PANEL A LOT VRA459 DURING ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR TWO PATIENTS USING AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD 092723001-11 IN COMBINATION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER SERIAL (B)(6) (SOFTWARE VERSION NOT PROVIDED). COMPLAINANT/COMPLAINT REPORTER NAME: MARGIE MOON, LABORATORY SUPERVISOR. EVENTS DATES: 29 AND 30 MAY 2024. PATIENT INFORMATION: PATIENT 1 KNOWN TO HAVE AN ANTI-E(RH3) ANTIBODY. ANTIBODY SCREENING POSITIVE 3+ WITH CELL 2 OF 0.8% SELECTOGEN LOT VS593, BEING E(RH3) ANTIGEN POSITIVE (HOMOZYGOUS). SAMPLE ID (B)(6) KNOWN TO HAVE AN ANTI-E(RH3) ANTIBODY. CUSTOMER EXPECTED POSITIVE REACTIONS WITH CELL 3 (R2R2) OF 0.8% RESOLVE PANEL A LOT VRA459. NO FURTHER INFORMATION PROVIDED. REAGENTS 0.8% RESOLVE PANEL A LOT VRA459 (PRODUCT CODE 6902317; EXPIRY DATE 25 JUNE 2024; MANUFACTURE DATE 23 APRIL 2024) ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660797 ↗
• MalfunctionJul 2, 2024False Negative Result; False Negative Result

  CMS (B)(4) AND (B)(6), WINDCHILL (B)(4) REPORT 2 OF 3 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 07 JUNE 2024 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS WITH CELL 3 (R2R2) OF 0.8% RESOLVE PANEL A LOT VRA459 DURING ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR TWO PATIENTS USING AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD 092723001-11 IN COMBINATION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER SERIAL (B)(6) (SOFTWARE VERSION NOT PROVIDED). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), LABORATORY SUPERVISOR. EVENTS DATES: 29 AND 30 MAY 2024. PATIENT INFORMATION: PATIENT 1 KNOWN TO HAVE AN ANTI-E(RH3) ANTIBODY. ANTIBODY SCREENING POSITIVE 3+ WITH CELL 2 OF 0.8% SELECTOGEN LOT VS593, BEING E(RH3) ANTIGEN POSITIVE (HOMOZYGOUS). SAMPLE ID (B)(6) SAMPLE ID (B)(6) KNOWN TO HAVE AN ANTI-E(RH3) ANTIBODY. CUSTOMER EXPECTED POSITIVE REACTIONS WITH CELL 3 (R2R2) OF 0.8% RESOLVE PANEL A LOT VRA459. NO FURTHER INFORMATION PROVIDED. REAGENTS 0.8% RESOLVE PANEL A LOT VRA459 (PRODUCT CODE 6902317; EXPIRY DATE 25 JUNE 2024; MANUFACTURE DATE 23 APRIL 2024) ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660676 ↗
• MalfunctionJul 2, 2024False Negative Result; False Negative Result

  CMS 2627588, (B)(4) REPORT 2 OF 2 A CUSTOMER CONTACTED ORTHO'S GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 07JUN2024 TO REPORT DISCORDANT NEGATIVE RESULTS FOR ANTIBODY SCREENING AND ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT KNOWN TO HAVE ANTI-E USING 0.8% SELECTOGEN FOR GEL LOT VS593 EXPIRY 11JUN2024 AND 0.8% RESOLVE PANEL A LOT VRA458 EXPIRY 11JUN2024 IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOT 082223001-07 WITH THEIR ORTHO VISION ID-MTS ANALYZER ((B)(6)). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), MEDICAL TECHNOLOGIST COMPLAINANT CONTACT INFO: (B)(6); EVENT DATE: 01JUN2024, REPORTED 07JUN2024 REAGENTS: 0.8% SELECTOGEN LOT VS593, EXPIRY 11JUN2024, MANUFACTURE 09APR2024 MTS ANTI-IGG GEL CARD LOT 082223001-07, EXPIRY 04JUL2024 0.8% RESOLVE PANEL A LOT VRA458, EXPIRY11JUN2024, MANUFACTURE 09APR2024 0.8% RESOLVE PANEL B LOT VRB323, EXPIRY11JUN2024, MANUFACTURE 09APR2024 PATIENT INFORMATION: HISTORICAL O RH POSITIVE WITH ANTI-E, ANTI-JKA AND ANTI-LUA SAMPLE ID: (B)(6), (ENCRYPTED: AD-59-0B-01-CE-9A-EF-AE-1D-96-69-FF-3F-EA-4F-2C-6E-20-CB-40-C2-1A-57-B6-F0-4E-4D-72-68-21-9F-C5) CUSTOMER INDICATED ONE PATIENT SAMPLE WAS AFFECTED. PATIENT HAD A HISTORIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658357 ↗
• MalfunctionJun 26, 2024False Negative Result; False Negative Result

  CMS (B)(4), WINDCHILL RA606433 A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 20224 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS AGAINST MULTIPLE PANEL CELLS FOR ONE PATIENT SAMPLE FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% RESOLVE PANEL A LOT VRA458 EXPIRY 11JUN2024 AND MTS ANTI-IGG GEL CARD LOT 072523001-05 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) HOSPITAL EVENT DATES: 22MAY2024 AND 23MAY2024, REPORTED ON (B)(6) 2024. REAGENTS: 0.8% RESOLVE PANEL A LOT VRA458, EXPIRY 11JUN2024, MANUFACTURE DATE: 09APR2024 0.8% RESOLVE PANEL B LOT VRB323, 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: (B)(6) 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 CUSTOMER REPORTED THAT ON (B)(6) 2024, THEY HAD TESTED ONE PATIENT SAMPLE FOR ANTIBODY IDENTIFICATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618923 ↗
• MalfunctionOct 6, 2023False Negative Result; False Negative Result

  MXP2555867_75 WINDCHILL RA603564 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 07SEP2023 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE RESULTS WITH CELL 4 OF ONE PATIENT SAMPLE FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% RESOLVE PANEL A. LOT: VRA440. EXPIRY: 03OCT2023(MANUFACTURING DATE 01AUG2023) AND MTS ANTI-IGG GEL CARD. LOT: 022423001-01. EXPIRY: 17DEC2023. (MANUFACTURING DATE 17MAR2023) IN CONJUNCTION WITH THEIR ORTHO VISION (50002852) AND ORTHO WORKSTATION (510010467). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), MEDICAL, TECHNOLOGIST COMPLAINANT CONTACT INFO: +(B)(6). CUSTOMER, # (B)(6) HOSPITAL INC (B)(6) GEORGIA 30060. EVENT DATE: (B)(6) 2023, REPORTED SAME DAY. METHOD: AUTOMATED ¿ ORTHO VISION 50002852 (INSTALL DATE: (B)(6) 2018), SW VERSION 5.12.4.46568). MANUAL ¿ ORTHO WORKSTATION 510010467, (INSTALL DATE: (B)(6) 2020) REAGENTS: 0.8% RESOLVE PANEL A LOT VRA440 EXPIRY 03OCT2023, MANUFACTURE DATE: 01AUG2023, MTS ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS GEL CARD LOT 022423001-01. EXPIRY: 17DEC2023, MANUFACTURE DATE: 17MAR2023. PATIENT INFORMATION: KNOWN ANTI-FYA ANTIBODY POSITIVE. NO OTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886956 ↗
• MalfunctionOct 2, 2023False Negative Result; False Negative Result

  REPORT 2 OF 2 (B)(4), WINDCHILL RA603340 A CUSTOMER CONTACTED GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT FALSE NEGATIVE ANTIBODY IDENTIFICATION RESULTS FOR ANTI-LITTLE C FOR TWO PATIENT SAMPLES USING ORTHO 0.8% RESOLVE PANEL A AND MTS ANTI-IGG GEL CARDS WHILE TESTING ON TWO ORTHO VISION ID-MTS ANALYZERS. COMPLAINANT/COMPLAINT REPORTER NAME:(B)(6), LABORATORY SUPERVISOR (B)(6); CREATIVE TESTING SOLUTIONS (B)(6) (CUST#(B)(6)) EVENT DATES:(B)(6) 2023, REPORTED 03SEP2023 REAGENTS: 0.8% RESOLVE PANEL A LOT VRA438 (EXPIRY 05SEP2023, MANUFACTURED 04JUL2023) 0.8% SURGISCREEN LOT VSS483 (EXPIRY 05SEP2023, MANUFACTURED 04JUL2023) MTS ANTI-IGG CARD LOT 090622001-07 (EXPIRY: 05JAN2024, MANNFACTURED 05APR2023) 0.8% RESOLVE PANEL B LOT INFORMATION NOT PROVIDED. PATIENT INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT TWO PATIENT SAMPLES WERE TESTED ON ORTHO VISION INSTRUMENTS (SERIAL NUMBERS (B)(6)) USING 0.8% RESOLVE PANEL A LOT VRA438 (EXPIRY 05SEPT2023) IN MTS ANTI-IGG GEL CARD LOT 090622001-07 (EXPIRY 05JAN2024) AND THAT BOTH SAMPLES RESULTED WITH ALL NEGATIVE CELLS FOR 0.8% RESOLVE PANEL A AFTER TESTING POSITIVE FOR CELL TWO OF ANTIBODY SCREEN USING 0.8% SURGISCREEN LOT VSS483 (E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857058 ↗
• MalfunctionOct 2, 2023False Negative Result; False Negative Result

  REPORT 1 OF 2 MXP2554709 AND 2554713, WINDCHILL RA603340 A CUSTOMER CONTACTED GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT FALSE NEGATIVE ANTIBODY IDENTIFICATION RESULTS FOR ANTI-LITTLE C FOR TWO PATIENT SAMPLES USING ORTHO 0.8% RESOLVE PANEL A AND MTS ANTI-IGG GEL CARDS WHILE TESTING ON TWO ORTHO VISION ID-MTS ANALYZERS. COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), LABORATORY SUPERVISOR (B)(6); CREATIVE TESTING SOLUTIONS PHOENIX (CUST#1122482) EVENT DATES: (B)(6) 2023 AND (B)(6) 2023, REPORTED 03SEP2023 REAGENTS: 0.8% RESOLVE PANEL A LOT VRA438 (EXPIRY 05SEP2023, MANUFACTURED 04JUL2023) 0.8% SURGISCREEN LOT VSS483 (EXPIRY 05SEP2023, MANUFACTURED 04JUL2023) MTS ANTI-IGG CARD LOT 090622001-07 (EXPIRY: 05JAN2024, MANNFACTURED 05APR2023) 0.8% RESOLVE PANEL B LOT INFORMATION NOT PROVIDED. PATIENT INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT TWO PATIENT SAMPLES WERE TESTED ON ORTHO VISION INSTRUMENTS (SERIAL NUMBERS (B)(6) AND (B)(6)) USING 0.8% RESOLVE PANEL A LOT VRA438 (EXPIRY 05SEPT2023) IN MTS ANTI-IGG GEL CARD LOT 090622001-07 (EXPIRY 05JAN2024) AND THAT BOTH SAMPLES RESULTED WITH ALL NEGATIVE CELLS FOR 0.8% RESOLVE PANEL A AFTER TESTING POSITIVE FOR CELL TWO OF ANTIB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856686 ↗
• MalfunctionSep 26, 2023False Negative Result; False Negative Result

  (B)(4) ON 29 AUGUST 2023, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE REACTIONS IN ANTIBODY IDENTIFICATION FOR ONE PATIENT SAMPLE USING 0.8% RESOLVE PANEL A LOT VRA439 IN MANUAL METHOD USING ORTHO WORKSTATION (B)(4). DATE OF EVENTS: (B)(6) 2023. COMPLAINANT/COMPLAINT REPORTER: (B)(6)- LABORATORY MANAGER REPORTED ON 26 AUGUST 2023 BY THE CUSTOMER TO THE GTSC. REAGENTS: 0.8% RESOLVE PANEL A LOT VRA439, EXPIRY 19 SEPTEMBER 2023 0.8% RESOLVE PANEL A LOT VRA438, EXPIRY 05 SEPTEMBER 2023 0.8% SELECTOGEN LOT VS537, EXPIRY 19 SEPTEMBER 2023 MTS ANTI-IGG GEL CARD LOT 02242300-03, EXPIRY 25 JANUARY 2024 PATIENT HISTORY: LAST RECEIVED A TRANSFUSION ON (B)(6) 2022 KNOWN ANTI-C(RH2) ANTIBODY. THE CUSTOMER REPORTED THAT, ON 26 AUGUST 2023, THEY HAD TESTED A PATIENT SAMPLE FOR ANTIBODY SCREENING IN THE INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SELECTOGEN LOT VS537 AND MTS ANTI-IGG GEL CARD LOT 02242300-03, AND THAT THEY HAD OBTAINED A POSITIVE REACTION WITH CELL 1. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT, ON THE SAME DAY, THEY HAD TESTED THE SAME PATIENT SAMPLE TWICE FOR ANTIBODY IDENTIFICATION (IAT) USI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821677 ↗
• MalfunctionSep 22, 2023False Negative Result; False Negative Result

  MXP2552433 WINDCHILL RA603188 (B)(6) 2023, A CUSTOMER COMPLAINED TO ORTHO GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) ABOUT WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE ANTIBODY IDENTIFICATION RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT¿S SAMPLE USING 0.8% RESOLVE PANEL A LOT VRA438 IN CONJUNCTION WITH THEIR ORTHO WORKSTATION ID-MTS (J51002423). COMPLAINANT/COMPLAINT REPORTER: STEPHEN GOLDING ¿ LABORATORY MANAGER DATE OF EVENT:(B)(6) 2023 REPORTED ON (B)(6) 2023 BY STEPHEN GOLDING TO ORTHO GTSC REAGENTS: 0.8% RESOLVE PANEL A LOT VRA438 EXPIRY DATE 05 SEPTEMBER 2023 ANTIBODY SCREENING REAGENT RED CELLS AND MTS CARD TYPE LOTS AND EXPIRY DATES NOT PROVIDED. 0.8% RESOLVE PANEL B LOT AND EXPIRY DATE NOT PROVIDED. PATIENT¿S INFORMATION: NO INFORMATION PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED A SAMPLE FROM THIS PATIENT FOR ANTIBODY SCREENING IN IAT AND THAT THEY OBTAINED AN OVERALL POSITIVE RESULT (NO FURTHER INFORMATION WAS PROVIDED). THE CUSTOMER REPORTED THAT THE SAME DAY THEY HAD TESTED THIS PATIENT¿S SAMPLE FOR ANTIBODY IDENTIFICATION IN IAT USING 0.8% RESOLVE PANEL A LOT VRA438 AND MTS CARDS (LOT NOT PROVIDED) WITH AND ORTHO WORKSTATION ID-M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797706 ↗
• MalfunctionSep 12, 2023False Negative Result; False Negative Result

  (B)(6) WINDCHILL RA603189. ON 22 AUGUST 2023, A CUSTOMER COMPLAINED TO ORTHO GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) ABOUT WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE ANTIBODY IDENTIFICATION RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT¿S SAMPLE USING 0.8% RESOLVE PANEL A LOT VRA438 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6) ¿ MEDICAL TECHNOLOGIST DATE OF EVENT: (B)(6) 2023. REPORTED ON 22 AUGUST 2023, SOFTWARE VERSION: 5.14.5 REAGENTS: 0.8% SELECTOGEN. LOT: VS532. EXPIRY DATE: 05 SEPTEMBER 2023, MTS ANTI-IGG CARD LOT 022423001-17 EXPIRY DATE 19 FEBRUARY 2024. 0.8% RESOLVE PANEL A LOT VRA438, EXPIRY DATE: 05 SEPTEMBER 2023 0.8%. RESOLVE PANEL C LOT VRC313. EXPIRY DATE: 05 SEPTEMBER 2023 PATIENT¿S INFORMATION: BLOOD GROUP A RHD POSITIVE; MYELODYSPLASTIC SYNDROME HISTORY OF ANTI-K(KEL1) AND UNSPECIFIC ANTIBODIES; NO HISTORY OF ANTI-E(RH3) ANTIBODY TRANSFUSED WITH ONE BLOOD UNIT (A RHD POSITIVE, E AND K ANTIGEN NEGATIVES) ON (B)(6) 2023. THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED A SAMPLE FROM THIS PATIENT FOR ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SELECTOGEN LOT: VS5

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733144 ↗
• MalfunctionAug 21, 2023False Negative Result; False Negative Result

  REPORT 1 OF 3 MXP2544433 WINDCHILL RA602931 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER ON 25JUL2023 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE RESULTS FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR THREE PATIENTS USING 0.8% RESOLVE® PANEL A LOT VRA436 EXPIRY 08AUG2023 (MANUFACTURING DATE 06JUN2023). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6); LABORATORY MANAGER COMPLAINANT CONTACT INFO: (B)(6) EVENT DATE: (B)(6)2023. PATIENT INFORMATION: CUSTOMER INDICATED THREE PATIENT SAMPLES WERE AFFECTED, BUT ONLY PROVIDED TEST INFORMATION FOR ONE PATIENT WITH A HISTORICAL ANTI-E(RH3) ANTIBODY. NO TRANSFUSION HISTORY PROVIDED. PATIENT¿S ANTIBODY SCREENING WAS POSITIVE 1+ WITH CELL 2 BEING E(RH3) ANTIGEN POSITIVE (HOMOZYGOUS) WITH 0.8% SURGISCREEN LOT VSS476, EXPIRY 08AUG2023. THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED THE PATIENT SAMPLES FOR ANTIBODY IDENTIFICATION IN IAT USING 0.8% RESOLVE PANEL A LOT VRA436 AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS GEL CARD LOT 120222001-19, EXPIRY 16NOV2023, IN MANUAL GEL TECHNIQUE AND THAT THEY OBTAINED NEGATIVE REACTIONS WITH ALL PANEL CELLS. CUSTOMER FURTHER TESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584281 ↗
• MalfunctionAug 21, 2023False Negative Result; False Negative Result

  REPORT 3 OF 3 MXP2544433 WINDCHILL RA602931 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER ON 25JUL2023 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE RESULTS FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR THREE PATIENTS USING 0.8% RESOLVE® PANEL A LOT VRA436 EXPIRY 08AUG2023 (MANUFACTURING DATE 06JUN2023). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6); LABORATORY MANAGER COMPLAINANT CONTACT INFO: (B)(6); (B)(6). CUSTOMER #5056. (B)(6) MEDICAL CENTER. EVENT DATE: (B)(6) 2023. PATIENT INFORMATION: CUSTOMER INDICATED THREE PATIENT SAMPLES WERE AFFECTED, BUT ONLY PROVIDED TEST INFORMATION FOR ONE PATIENT WITH A HISTORICAL ANTI-E(RH3) ANTIBODY. NO TRANSFUSION HISTORY PROVIDED. PATIENT¿S ANTIBODY SCREENING WAS POSITIVE 1+ WITH CELL 2 BEING E(RH3) ANTIGEN POSITIVE (HOMOZYGOUS) WITH 0.8% SURGISCREEN LOT VSS476, EXPIRY 08AUG2023. THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED THE PATIENT SAMPLES FOR ANTIBODY IDENTIFICATION IN IAT USING 0.8% RESOLVE PANEL A LOT VRA436 AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS GEL CARD LOT 120222001-19, EXPIRY 16NOV2023, IN MANUAL GEL TECHNIQUE AND THAT THEY OBTAINED NEGATIVE REACTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17582529 ↗
• MalfunctionAug 21, 2023False Negative Result; False Negative Result

  REPORT 2 OF 3 MXP2544433 WINDCHILL RA602931 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER ON 25JUL2023 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE RESULTS FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR THREE PATIENTS USING 0.8% RESOLVE® PANEL A LOT VRA436 EXPIRY 08AUG2023 (MANUFACTURING DATE 06JUN2023). COMPLAINANT/COMPLAINT REPORTER NAME:(B)(6) MEDICAL CENTER EVENT DATE: (B)(6) 2023. PATIENT INFORMATION: CUSTOMER INDICATED THREE PATIENT SAMPLES WERE AFFECTED, BUT ONLY PROVIDED TEST INFORMATION FOR ONE PATIENT WITH A HISTORICAL ANTI-E(RH3) ANTIBODY. NO TRANSFUSION HISTORY PROVIDED. PATIENT¿S ANTIBODY SCREENING WAS POSITIVE 1+ WITH CELL 2 BEING E(RH3) ANTIGEN POSITIVE (HOMOZYGOUS) WITH 0.8% SURGISCREEN LOT VSS476, EXPIRY 08AUG2023. THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED THE PATIENT SAMPLES FOR ANTIBODY IDENTIFICATION IN IAT USING 0.8% RESOLVE PANEL A LOT VRA436 AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS GEL CARD LOT 120222001-19, EXPIRY 16NOV2023, IN MANUAL GEL TECHNIQUE AND THAT THEY OBTAINED NEGATIVE REACTIONS WITH ALL PANEL CELLS. CUSTOMER FURTHER TESTED THE PATIENT SAMPLES USING R2R2 CELLS (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17582452 ↗
• MalfunctionAug 15, 2023False Negative Result; False Negative Result

  MXP2546955 WINDCHILL RA602982 A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER ON 03AUG2023 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE RESULTS FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT USING 0.8% RESOLVE PANEL A LOT VRA436 EXPIRY 08AUG2023. COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6). LABORATORY SUPERVISOR COMPLAINANT CONTACT INFO: (B)(6). CUSTOMER #(B)(6); (B)(6) HOSPITAL REAGENTS: 0.8% RESOLVE PANEL A LOT VRA436 EXPIRY 08AUG2023 (MANUFACTURE DATE: 06JUN2023) 0.8% SELECTOGEN LOT VS527 EXPIRY 08AUG2023 (MANUFACTURE DATE 06JUN2023) MTS ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS GEL CARD LOT 090622001-10 EXPIRY 10JAN2024 (MANUFACTURE DATE 20APR2023) EVENT DATE: (B)(6)2023. PATIENT INFORMATION: CUSTOMER INDICATED ONE PATIENT SAMPLE WAS AFFECTED. CUSTOMER HAD NO PRIOR HISTORY FOR THE PATIENT. PATIENT¿S ANTIBODY SCREENING WAS PERFORMED WITH 0.8% SELECTOGEN LOT VS527. A POSITIVE 1+ REACTION WAS OBSERVED WITH CELL 2 BEING E(RH3) ANTIGEN POSITIVE (HOMOZYGOUS). THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED THE PATIENT SAMPLE FOR ANTIBODY IDENTIFICATION IN IAT USING 0.8% RESOLVE PANEL A LOT VRA436 AND ANTI-HUMAN GLOBULIN A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549430 ↗
• MalfunctionAug 15, 2023False Negative Result; False Negative Result

  MXP2543089 WINDCHILL RA602909 A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER ON 19 JULY 2023 AFTER OBSERVING WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE RESULT FOR ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT USING 0.8% RESOLVE® PANEL A LOT VRA434 EXPIRY DATE 11 JULY 2023 (MANUFACTURING DATE 09 MAY 2023). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), MEDICAL TECHNOLOGIST. EVENT DATE: (B)(6) 2023. PATIENTS INFORMATION: ANTIBODY SCREENING POSITIVE 1+ WITH CELL 2 BEING E(RH3) ANTIGEN POSITIVE (HOMOZYGOUS) (PRODUCT CODE 690316; LOT VSS472, EXPIRY DATE 11 JULY 2023). POLY-TRANSFUSED PATIENT DETERMINED TO HAVE A MIX OF ANTI-JKA(JK1) AND ANTI-E(RH3) ANTIBODIES NUMBER OF UNIT/TRANSFUSION DATES PROVIDED AS FOLLOWS: 1 UNIT/(B)(6) 2023 1 UNIT/(B)(6) 2023 1 UNIT/(B)(6) 2023 2 UNITS/(B)(6) 2023 2 UNITS/(B)(6) 2023 1 UNIT/(B)(6) 2023 2 UNITS/(B)(6) 2023 THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED A SAMPLE FROM THIS PATIENT ANTIBODY IDENTIFICATION IN IAT USING 0.8% RESOLVE® PANEL A LOT VRA434 AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD LOT 021023001-06 (EXPIRY DATE 22 MARCH 2023) IN COMBINATION WITH THEIR ORTHO VISION¿ ID-MTS AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547757 ↗