SELECTOGEN 6902315Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10758750007653), received between Oct 27, 2023 and Apr 11, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026False Negative Result

  REPORT 2 OF 2 CMS (B)(4) / RA613978 ON 16MAR2026, 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) CUSTOMER (B)(6);(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) (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847080 ↗
• MalfunctionApr 10, 2026False Negative Result

  CMS 100847100 / RA613978 ON 16MAR2026, 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); (B)(6) CANADA 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 1 WAS COLLECTED ON (B)(6) 2026 IN A (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840787 ↗
• MalfunctionApr 10, 2026False Negative Result

  REPORT 1 OF 2 (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) CUSTOMER (B)(6); (B)(6) HOSPITAL (B)(6) DATES OF EVENTS: 04 AND 13MAR2026; REPORTED (B)(6) 2026 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)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840532 ↗
• MalfunctionAug 22, 2025False Negative Result; False Negative Result

  (B)(4) ON 31JUL2025, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS A FALSE NEGATIVE ANTIBODY SCREEN RESULT FOR ONE PATIENT SAMPLE ON THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (50004200) USING 0.8% SELECTOGEN LOT VS717, EXPIRY 05AUG2025, IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOT 031125001-08, EXPIRY 22JAN2026. COMPLAINANT:(B)(6); LABORATORY TECHNICIAN (B)(6); (B)(6) CUSTOMER (B)(6) HOSPITAL, (B)(6)CANADA DATE OF EVENT: 30JUL2025; REPORTED 31JUL2025 EQUIPMENT: ORTHO VISION SWIFT ID-MTS ANALYZER (B)(6) SW VERSION: 5.16.0 (INSTALL DATE: (B)(6) 2022) REAGENTS: 0.8% SELECTOGEN LOT VS717, EXPIRY 05AUG2025, MANUFACTURED 03JUN2025 MTS ANTI-IGG GEL CARD LOT 031125001-08, EXPIRY 22JAN2026, MANUFACTURED 22APR2025 0.8% RESOLVE PANEL B LOT VRB339, EXPIRY 05AUG2025 0.8% SELECTOGEN LOT VS723, EXPIRY 05AUG2025 PATIENT INFORMATION: PREGNANT FEMALE, O-POSITIVE, WITH HISTORY OF ANTI-E(RH3). SAMPLE ID: (B)(6) ENCRYPTED ID: (B)(6) THE CUSTOMER REPORTED THAT ON (B)(6) 2025, A SAMPLE FROM A PREGNANT PATIENT WITH A HISTORY OF ANTI-E(RH3) WAS TESTED FOR ANTIBODY SCREENING USING 0.8% SELECTOGEN LOT VS717 AND MTS ANTI-IGG GEL CARD LOT 031125001-08 IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22871937 ↗
• MalfunctionJun 20, 2025False Negative Result; False Negative Result

  (B)(4) / WINDCHILL (B)(4), ON 22 MAY 2025, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE REACTIONS IN ANTIBODY SCREENING USING 0.8% SELECTOGEN LOT VS703 IN MANUAL METHOD. DATE OF EVENTS: 22 MAY 2025, AWARENESS DATE: 22 MAY 2025, COMPLAINANT/COMPLAINT REPORTER: (B)(6) - DIRECTOR OF LABORATORY SERVICES REPORTED ON 22 MAY 2025 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENT: 0.8% SELECTOGEN (PRODUCT CODE 6902315; LOT VS703, EXPIRY 10 JUNE 2025; MANUFACTURED 08 APRIL 2025) MTS ANTI-IGG GEL CARD (PRODUCT CODE MTS084024; LOT 012825001-05; EXPIRY 25 NOVEMBER 2024; MANUFACTURED 28 FEBRUARY 2025) PATIENT HISTORY: CUSTOMER TRANSFUSED FREQUENTLY (NO DETAIL PROVIDED) BLOOD GROUP B(ABO2) RHD POSITIVE. CUSTOMER TESTED POSITIVE FOR ANTIBODY SCREEN ON (B)(6) 2025, NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT, ON (B)(6) 2025, THEY HAD TESTED A PATIENT SAMPLE TWICE FOR ANTIBODY SCREENING IN THE INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SELECTOGEN LOT VS703 AND MTS ANTI-IGG GEL CARD LOT 012825001-05 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE 2 CELLS OF THE RED CELL REAGENT ON BOTH OCCASIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298216 ↗
• MalfunctionMar 14, 2025False Negative Result; False Negative Result

  CMS (B)(4) WINDCHILL (B)(4) 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: (B)(6), BLOOD BANK LEAD, (B)(6); COMPLAINT REPORTER NAME: (B)(6), QUIDELORTHO ACCOUNT MANAGER (AM). REPORTED DATE: (B)(6) REPORTED THE EVENTS ON 26FEB2025 TO QUIDELORTHO AM WHO REPORTED IT ON THE 27FEB2025 TO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) UP HEALTH SYSTEM MARQUETTE (CUSTOMER NUMBER: (B)(4)) 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: PATIENT SAMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605736 ↗
• MalfunctionJan 17, 2025False Negative Result; False Negative Result

  CMS 2679417 AND 2681004; WINDCHILL (B)(4) ON 31DEC2024 A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE REACTION GRADING OF BOTH CELLS DURING ANTIBODY SCREENING TESTING OF ONE PATIENT SAMPLE WITH A KNOWN ANTI-E USING THE ORTHO VISION ID-MTS ANALYZER EQUIPPED WITH SOFTWARE VERSION 5.16.0.47707. COMPLAINANT: (B)(6) EVENT DATE: 31DEC2024, AWARENESS DATE: 31DEC2024 VISION (B)(4), INSTALL DATE: 12DEC2018; SW VERSION: 5.16.0.47707 REAGENTS: 0.8% SELECTOGEN LOT VS671, EXPIRATION DATE:07JAN2025; MANUFACTURED:05NOV2024 PATIENT/SAMPLE INFORMATION: HISTORICAL ANTI-E. SAMPLE ID: (B)(6) (ENCRYPTED SAMPLE ID: (B)(6)) THE CUSTOMER STATED THAT ON (B)(6) 2024, THEY TESTED ONE PATIENT SAMPLE FOR ANTIBODY SCREEN USING 0.8% SELECTOGEN LOT VS671 IN CONJUNCTION WITH THE ORTHO VISION ID-MTS ANALYZER AND THAT THE REACTION GRADE FOR BOTH CELLS WAS INDICATED AS NEGATIVE AND THE RESULT WAS REPORTED AS NEGATIVE BY THE ANALYZER. THE CUSTOMER ALSO STATED THAT THEY VISUALLY INSPECTED THE IMAGE OF THE MTS ANTI-IGG GEL CARD AND INDICATED THAT THEY WOULD HAVE GRADED THE REACTION OBTAINED FOR CELL 2 AS POSITIVE. THE CUSTOMER REPORTS NO BIASED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177619 ↗
• MalfunctionOct 30, 2024False Negative Result; False Negative Result

  CMS (B)(4), WINDCHILL (B)(6) A CUSTOMER CONTACTED ORTHO'S GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2024 TO REPORT DISCORDANT NEGATIVE RESULTS FOR ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT, WITH A HISTORICAL ANTI-LITTLE C, USING 0.8% SELECTOGEN FOR GEL LOT VS625 (EXPIRY 29OCT2024) IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOT 042924001-07 WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(4). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6) HOSPITAL; EVENT DATES: (B)(6) 2024, REPORTED (B)(6) 2024 REAGENTS: 0.8% SELECTOGEN FOR GEL LOT VS625, EXPIRY 29OCT2024, MANUFACTURED 27AUG2024 MTS ANTI-IGG GEL CARD LOT 042924001-07, EXPIRY 21FEB2025 PATIENT INFORMATION: PREGNANT FEMALE WITH A HISTORICAL ANTI-LITTLE C. ORIGINAL SAMPLE ID: (B)(6); (ENCRYPTED: (B)(6) CUSTOMER INDICATED ON (B)(6) 2024 ONE PATIENT SAMPLE WAS TESTED FOR ANTIBODY SCREEN ON THE ORTHO VISION ID-MTS ANALYZER IN CONJUNCTION WITH 0.8% SELECTOGEN FOR GEL LOT VS625 IN MTS ANTI-IGG GEL CARD LOT 042924001-07 AND THE RESULTS WERE UNEXPECTED. BOTH CELLS 1 AND 2 HAD NEGATIVE REACTIONS. THE FOLLOWING DAY, THE CUSTOMER REPEATED TESTING OF THE PATIENT SAMPLE USING THE SAME REAGENT LOTS AND ORTHO VISION ID-MT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565269 ↗
• MalfunctionJul 2, 2024False Negative Result; False Negative Result

  CMS 2627588, WINDCHILL (B)(4) REPORT 1 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658775 ↗
• MalfunctionOct 27, 2023False Negative Result; False Negative Result

  (B)(6) WINDCHILL (B)(6) ON (B)(6)2023, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER TO REPORT A DELAYED HEMOLYTIC TRANSFUSION REACTION AS A RESULT OF DISCORDANT NEGATIVE ANTIBODY REACTIONS OF THE ANTIBODY SCREENING FOR ONE PATIENT HAVING AN ANTI-C AND ANTI-K ANTIBODIES USING 0.8% SELECTOGEN LOT VS537, EXPIRY 19SEP2023, IN CONJUNCTION WITH MTS ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) GEL CARD LOT 061223001-17, EXPIRY 26APR2024, WITH THE ORTHO VISION ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6) ¿ LABORATORY SUPERVISOR (B)(6), (B)(6). DATE OF EVENT: ORIGINAL TESTING - (B)(6) 2023, IDENTIFIED DISCORDANT RESULTS ¿ (B)(6) 2023 REPORTED ON: (B)(6)2023 REAGENTS: 0.8% SELECTOGEN LOT VS537, EXPIRY 19SEP2023, MANUFACTURE DATE 18JUL2023 MTS ANTI-IGG GEL CARD LOT 061223001-17, EXPIRY 26APR2024, MANUFACTURE DATE 26JUL2023 0.8% SELECTOGEN LOT VS542, EXPIRY 17OCT2023, MANUFACTURE DATE 15AUG2023 0.8% RESOLVE PANEL A LOT VRA440, EXPIRY 03OCT2023 PATIENT INFORMATION: PATIENT HAD A PRIOR HISTORY OF AUS (ANTIBODY OF UNKNOWN SPECIFICITY) REPORTED IN (B)(6)2023 AS PER CUSTOMER. PATIENT DIAGNOSIS AT THE TIME OF INITIAL TESTING WAS RIGHT SHOULDER PAIN. PATIENT WAS TRANSFUSED WITH TWO UN

  Patient problems: Hyperbilirubinemia

  MAUDE report 18021213 ↗