AFFIRMAGEN 719201Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10758750003877), received between Jul 24, 2025 and Feb 9, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionFeb 9, 2026False Negative Result

  (B)(4) / RA613355 COMPLAINT DESCRIPTION: ON (B)(6) 2026, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE RESULTS WITH THE 0.8% AFFIRMAGEN A1 CELLS LOTS 8A052 AND 8A069 AND ORTHO MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-09 WHEN PERFORMING ABO TESTING FOR TWO PATIENT SAMPLES IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6) - MEDICAL TECHNOLOGIST DATE OF EVENTS: 01 AND 14 JANUARY 2026 REPORTED ON: (B)(6) 2026 BY (B)(6) TO ORTHO GTSC REAGENTS: 0.8% AFFIRMAGEN LOT 8A052 EXPIRY DATE 03 FEBRUARY 2026 MANUFACTURE DATE 18 NOVEMBER 2025 0.8% AFFIRMAGEN LOT 8A069 EXPIRY DATE 03 MARCH 2026 MANUFACTURE DATE 16 DECEMBER 2025 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-09 EXPIRY DATE 08 MAY 2026 MANUFACTURE DATE 08 AUGUST 2025 PATIENT INFORMATION: PATIENT ONE: SAMPLE ID (B)(6) PATIENT TWO: SAMPLE ID (B)(6) THE CUSTOMER REPORTED THAT THEY HAD TESTED SAMPLES FROM TWO PATIENTS FOR ABO FORWARD AND REVERSE GROUPING AND THAT THEY HAD OBTAINED THE FOLLOWING PATTERN OF REACTIONS: DATE OF TESTING PATIENT SAMPLE ID REAGENTS ANALYZER RESULTS (B)(6) 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290468 ↗
• MalfunctionFeb 9, 2026False Negative Result

  REPORT 2 OF 2 CMS (B)(6)/ RA613355 COMPLAINT DESCRIPTION: ON 14 JANUARY 2026, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE RESULTS WITH THE 0.8% AFFIRMAGEN A1 CELLS LOTS 8A052 AND 8A069 AND ORTHO MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-09 WHEN PERFORMING ABO TESTING FOR TWO PATIENT SAMPLES IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6) - MEDICAL TECHNOLOGIST DATE OF EVENTS: 01 AND 14 JANUARY 2026 REPORTED ON: 14 JANUARY 2026 BY (B)(6) TO ORTHO GTSC REAGENTS: 0.8% AFFIRMAGEN LOT 8A052 EXPIRY DATE 03 FEBRUARY 2026 MANUFACTURE DATE 18 NOVEMBER 2025 0.8% AFFIRMAGEN LOT 8A069 EXPIRY DATE 03 MARCH 2026 MANUFACTURE DATE 16 DECEMBER 2025 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-09 EXPIRY DATE 08 MAY 2026 MANUFACTURE DATE 08 AUGUST 2025 PATIENT INFORMATION: PATIENT ONE: SAMPLE ID (B)(6) PATIENT TWO: SAMPLE ID (B)(6) THE CUSTOMER REPORTED THAT THEY HAD TESTED SAMPLES FROM TWO PATIENTS FOR ABO FORWARD AND REVERSE GROUPING AND THAT THEY HAD OBTAINED THE FOLLOWING PATTERN OF REACTIONS: DATE OF TESTING PATIENT SAMPLE ID REAGENTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290462 ↗
• MalfunctionFeb 9, 2026False Negative Result

  REPORT 1 OF 2 (B)(6)/ (B)(4) COMPLAINT DESCRIPTION: ON (B)(6) 2026, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE RESULTS WITH THE 0.8% AFFIRMAGEN A1 CELLS LOTS 8A052 AND 8A069 AND ORTHO MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-09 WHEN PERFORMING ABO TESTING FOR TWO PATIENT SAMPLES IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER:(B)(6) - MEDICAL TECHNOLOGIST DATE OF EVENTS: 01 AND 14 JANUARY 2026 REPORTED ON: (B)(6) 2026 BY (B)(6) TO ORTHO GTSC REAGENTS: 0.8% AFFIRMAGEN LOT 8A052 EXPIRY DATE 03 FEBRUARY 2026 MANUFACTURE DATE 18 NOVEMBER 2025 0.8% AFFIRMAGEN LOT 8A069 EXPIRY DATE 03 MARCH 2026 MANUFACTURE DATE 16 DECEMBER 2025 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-09 EXPIRY DATE 08 MAY 2026 MANUFACTURE DATE 08 AUGUST 2025 PATIENT INFORMATION: PATIENT ONE: SAMPLE ID (B)(6) PATIENT TWO: SAMPLE ID (B)(6) THE CUSTOMER REPORTED THAT THEY HAD TESTED SAMPLES FROM TWO PATIENTS FOR ABO FORWARD AND REVERSE GROUPING AND THAT THEY HAD OBTAINED THE FOLLOWING PATTERN OF REACTIONS: DATE OF TESTING PATIENT SAMPLE ID REAGENTS ANALYZER RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290438 ↗
• MalfunctionJul 24, 2025False Negative Result; False Negative Result

  CMS (B)(4) WINDCHILL RA611363 COMPLAINT DESCRIPTION: ON (B)(6) 2025, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS A FALSE NEGATIVE RESULT WITH THE 0.8% AFFIRMAGEN A1 CELLS LOT 8A943 WHEN PERFORMING ABO TESTING ON ONE PATIENT SAMPLE USING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 022825037-10 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(6). CUSTOMER NAME: (B)(6), MEDICAL TECHNOLOGIST (B)(6) CUSTOMER NO. (B)(6); (B)(6) HOSP, (B)(6) EVENT DATE: 12 JUNE 2025 AUTOMATED TESTING REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 022825037-10 (EXPIRY DATE 20 DECEMBER 2025, MANUFACTURED DATE 20 MARCH 2025) 0.8% AFFIRMAGEN LOT 8A943 (EXPIRY 24 JUNE 2025, MANUFACTURED DATE 08 APRIL 2025) MTS DILUENT 2 PLUS LOT MDP251 (EXPIRY DATE 12 FEBRUARY 2026, MANUFACTURED DATE 12 FEBRUARY 2025). PATIENT INFORMATION: THE PATIENT WAS BORN IN (B)(6) 1955. SAMPLE ID IS (B)(6). THE PATIENT RECEIVED SCIG HOME INFUSIONS. THE PATIENT HAS NOT BEEN TRANSFUSED. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6) 2025, ABO TESTING WAS PERFORMED ON ONE PATIENT SAMPLE USING MTS ABD MONOCLONAL AND REVERSE GROUPING CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586312 ↗