SURGISCREEN 719100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10758750003839), received between Mar 18, 2024 and Jan 30, 2026 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026False Negative Result

  REPORT 2 OF 2 (B)(4) A CUSTOMER CONTACTED ORTHO (B)(6) ON (B)(6) 2026 TO REPORT WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY SCREEN IN INDIRECT ANTIGLOBULIN TEST (IAT) USING MANUAL GEL METHOD, FOR TWO PATIENT SAMPLES UTILIZING REAGENT RED BLOOD CELLS SURGISCREEN LOT 3SS750 AND ORTHO MTS ANTI-IGG GEL CARD LOT 071025001-03 ON THEIR ORTHO WORKSTATION ID-(B)(4). COMPLAINANT: (B)(6) - MEDICAL TECHNOLOGIST; (B)(6); (B)(6) CUSTOMER (B)(6) HOSPITAL(B)(6) DATE OF EVENTS: 06JAN2026 AND 08JAN2026, REPORTED ON 08JAN2026 INSTRUMENT: ORTHO WORKSTATION ID-(B)(4) REAGENTS: SURGISCREEN LOT 3SS750, EXPIRATION: 20JAN2026, MANUFACTURE: 18NOV2025 MTS ANTI-IGG GEL CARD LOT 071025001-03, EXPIRATION: 30APR2026 MANUFACTURE: 31JUL2025 OTHER REAGENTS: 0.8% SURGISCREEN LOT VSS703, EXPIRATION: 20JAN2026 PATIENT INFORMATION: PATIENT 1- SAMPLE ID (B)(6), 29-YEAR-OLD PREGNANT FEMALE WITH CONFIRMED FETAL DEMISE AT 37-WEEKS GESTATION, DIAGNOSED WITH CHRONIC HYPERTENSION IN THE FIRST TRIMESTER AND ON MEDICATION SINCE. ANTI-M(MNS1) ANTIBODY NEWLY IDENTIFIED ON (B)(6) 2026. NO HISTORY OF PREVIOUS TRANSFUSIONS. PATIENT 2- SAMPLE ID (B)(6), 89-YEAR-OLD FEMALE. PREVIOUS HISTORY OF 8-9 YEARS ANEMIA, HY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226375 ↗
• MalfunctionJan 30, 2026False Negative Result

  REPORT 1 OF 2 (B)(4). A CUSTOMER CONTACTED (B)(4) ON (B)(6) 2026 TO REPORT WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY SCREEN IN INDIRECT ANTIGLOBULIN TEST (IAT) USING MANUAL GEL METHOD, FOR TWO PATIENT SAMPLES UTILIZING REAGENT RED BLOOD CELLS SURGISCREEN LOT 3SS750 AND ORTHO MTS ANTI-IGG GEL CARD LOT 071025001-03 ON THEIR ORTHO WORKSTATION ID-(B)(4). COMPLAINANT: (B)(6)- MEDICAL TECHNOLOGIST; (B)(6); (B)(6) CUSTOMER (B)(6) HOSPITAL (B)(6) DATE OF EVENTS: (B)(6) 2026 AND ( B)(6)2026, REPORTED ON 08JAN2026 INSTRUMENT: ORTHO WORKSTATION ID-MTS, (B)(6) REAGENTS: SURGISCREEN LOT 3SS750, EXPIRATION: 20JAN2026, MANUFACTURE: 18NOV2025 MTS ANTI-IGG GEL CARD LOT 071025001-03, EXPIRATION: 30APR2026 MANUFACTURE: 31JUL2025 OTHER REAGENTS: 0.8% SURGISCREEN LOT VSS703, EXPIRATION: 20JAN2026 PATIENT INFORMATION: PATIENT 1- SAMPLE ID (B)(6), 29-YEAR-OLD PREGNANT FEMALE WITH CONFIRMED FETAL DEMISE AT 37-WEEKS GESTATION, DIAGNOSED WITH CHRONIC HYPERTENSION IN THE FIRST TRIMESTER AND ON MEDICATION SINCE. ANTI-M(MNS1) ANTIBODY NEWLY IDENTIFIED ON (B)(6) 2026. NO HISTORY OF PREVIOUS TRANSFUSIONS. PATIENT 2- SAMPLE ID (B)(6), 89-YEAR-OLD FEMALE. PREVIOUS HISTORY OF 8-9 YEARS ANEMIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226274 ↗
• MalfunctionMar 18, 2024False Negative Result; False Negative Result

  (B)(4) WINDCHILL RA605440 ON 20FEB2024, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT ONE PATIENT SAMPLE IDENTIFIED TO HAVE ANTI-C PRODUCING FALSE NEGATIVE REACTIONS IN TUBE METHOD USING 3% SURGISCREEN LOT 3SS418 (EXPIRY 20FEB2024). COMPLAINANT/COMPLAINT REPORTER: (B)(6) ; MEDICAL TECHNOLOGIST; (B)(6); NO EMAIL CUSTOMER: 504126; (B)(6) HOSPITAL; (B)(6) EVENT OCCURRED ON (B)(6) 2024, REPORTED 20FEB2024. REAGENTS UNDER INVESTIGATION: 3% SURGISCREEN LOT 3SS418, EXPIRY 20FEB2024, MANUFACTURED 19DEC2023 OTHER REAGENTS: 0.8% RESOLVE PANEL A LOT VRA450, EXPIRY 20FEB2024 MTS ANTI-IGG CARD LOT NOT PROVIDED COMPETITOR REAGENTS AND SOLID PHASE METHODOLOGY DETAILS NOT PROVIDED. SAMPLE INFORMATION/PATIENT HISTORY: NO SAMPLE ID PROVIDED. PATIENT HAD HISTORICALLY NEGATIVE RESULTS AT THE CUSTOMER SITE; HOWEVER, AN ALTERNATE LOCAL HOSPITAL CONFIRMED ANTI-C IN 2018 AND REFERENCE LABORATORY CONFIRMED ANTI-C IN 2024. THE CUSTOMER REPORTED THAT ON (B)(6) 2024, ANTIBODY SCREEN TESTING WAS PERFORMED ON ONE PATIENT SAMPLE ON A COMPETITOR'S ANALYZER. RESULTS WERE POSITIVE. ANTIBODY IDENTIFICATION PANEL TESTING WAS ALSO COMPLETED ON THE ANALYZER. RESULTS WERE POSITIVE POTENTIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924456 ↗