MTS MTS080017Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10758750005871), received between Aug 8, 2024 and Jan 24, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025False Positive Result; False Positive Result

  REPORT 1 OF 2 CMS (B)(4), WINDCHILL RA608788 ON (B)(6)2025, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT FALSE POSITIVE RESULTS OF THE ANTI-B TYPING FOR TWO DONOR UNITS USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-12 (EXPIRY 20FEB2025) IN MANUAL GEL METHOD. CUSTOMER NAME: (B)(6) CUSTOMER# (B)(6), EVENT DATE: 08JAN2025, REPORTED (B)(6) 2025. REAGENT: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-12 (EXPIRY 20FEB2025, MANUFACTURED 20MAY2024) MANUAL METHOD USING ORTHO WORKSTATION ID-MTS (SERIAL (B)(6). DONOR UNIT IDS NOT PROVIDED BY THE CUSTOMER. BOTH UNITS WERE KNOWN TO BE BLOOD GROUP A UNITS. THE CUSTOMER REPORTED THAT ON (B)(6)2025, TWO DONOR UNITS WERE TESTED IN MANUAL GEL METHOD UTILIZING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-12, AND RESULTS DISPLAYED A DISCREPANT FORWARD TYPE OF AB WITH FALSE POSITIVE REACTIONS IN THE ANTI-B COLUMNS. THESE RESULTS DID NOT CORRELATE WITH THE EXPECTED RESULTS OF BLOOD GROUP A FOR THE UNITS. THE SAME DAY, THE CUSTOMER SITE TESTED THE SAME DONOR UNITS IN MANUAL GEL FOR AB GROUPING UTILIZING AN ALTERNATE MTS AB MONOCLONAL GROUPING CARD LOT. RESULTS WERE AS EXPECTED AND CON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228202 ↗
• MalfunctionJan 24, 2025False Positive Result; False Positive Result

  REPORT 2 OF 2 CMS (B)(4), WINDCHILL RA608788 ON 08JAN2025, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT FALSE POSITIVE RESULTS OF THE ANTI-B TYPING FOR TWO DONOR UNITS USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-12 (EXPIRY 20FEB2025) IN MANUAL GEL METHOD. CUSTOMER NAME: (B)(6), MEDICAL TECHNOLOGIST (B)(6) CUSTOMER (B)(6), EVENT DATE: 08JAN2025, REPORTED (B)(6)2025. REAGENT: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-12 (EXPIRY 20FEB2025, MANUFACTURED 20MAY2024) MANUAL METHOD USING ORTHO WORKSTATION ID-MTS (SERIAL (B)(6). DONOR UNIT IDS NOT PROVIDED BY THE CUSTOMER. BOTH UNITS WERE KNOWN TO BE BLOOD GROUP A UNITS. THE CUSTOMER REPORTED THAT ON (B)(6)2025, TWO DONOR UNITS WERE TESTED IN MANUAL GEL METHOD UTILIZING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-12, AND RESULTS DISPLAYED A DISCREPANT FORWARD TYPE OF AB WITH FALSE POSITIVE REACTIONS IN THE ANTI-B COLUMNS. THESE RESULTS DID NOT CORRELATE WITH THE EXPECTED RESULTS OF BLOOD GROUP A FOR THE UNITS. THE SAME DAY, THE CUSTOMER SITE TESTED THE SAME DONOR UNITS IN MANUAL GEL FOR AB GROUPING UTILIZING AN ALTERNATE MTS AB MONOCLONAL GROUPING CARD LOT. RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228008 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 10 OF 10 CMS 2637477 AND 2637491 WINDCHILL (B)(4) ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024 COMPLAINANT/COMPLAINT REPORTER: (B)(6), MEDICAL TECHNOLOGIST REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024 DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON 12,15 AND 16JUL2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968301 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 9 OF 10 CMS 2637477 AND 2637491 WINDCHILL (B)(6) ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024 COMPLAINANT/COMPLAINT REPORTER: (B)(6), MEDICAL TECHNOLOGIST REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024 DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON 12,15 AND 16JUL2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968202 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 8 OF 10 (B)(6) WINDCHILL RA607062 ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024 COMPLAINANT/COMPLAINT REPORTER:(B)(6) REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024 DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON 12,15 AND 16JUL2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH THE MTS ANTI-B(ABO2) GEL. THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968157 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 7 OF 10 CMS 2637477 AND 2637491 WINDCHILL RA607062 ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024 COMPLAINANT/COMPLAINT REPORTER: (B)(6) REPORTED ON (B)(6) 2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024 DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON 12,15 AND 16JUL2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH THE MTS ANTI-B(ABO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968110 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 1 OF 10 CMS (B)(4) WINDCHILL (B)(4) ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024. COMPLAINANT/COMPLAINT REPORTER: (B)(6), MEDICAL TECHNOLOGIST REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024 DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON (B)(6) 2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH THE MTS ANTI-B(ABO2)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968012 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 5 OF 10 CMS 2637477 AND 2637491 WINDCHILL RA607062 ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024 COMPLAINANT/COMPLAINT REPORTER: (B)(6), MEDICAL TECHNOLOGIST REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024 DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON (B)(6) 2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH THE MT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967900 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 4 OF 10 CMS (B)(4) AND (B)(4) WINDCHILL (B)(4) ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024. AWARENESS DATE: 17JUL2024. COMPLAINANT/COMPLAINT REPORTER: (B)(6), MEDICAL TECHNOLOGIST. REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD. LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024. MTS AB MONOCLONAL GROUPING CARD. LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024. DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON (B)(6) 2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967868 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 6 OF 10 CMS 2637477 AND 2637491 WINDCHILL (B)(4) ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024 COMPLAINANT/COMPLAINT REPORTER: KARLA ROSS, MEDICAL TECHNOLOGIST REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024 DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON 12,15 AND 16JUL2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967859 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 3 OF 10 CMS (B)(4) WINDCHILL RA607062. ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024 COMPLAINANT/COMPLAINT REPORTER: (B)(6). MEDICAL TECHNOLOGIST REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024; DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1). THE CUSTOMER REPORTED THAT, ON (B)(6) 2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR (B)(4) UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR (B)(4) UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR (B)(4) UNITS WITH T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967664 ↗
• MalfunctionAug 12, 2024False Positive Result; False Positive Result

  REPORT 2 OF 10 CMS (B)(4) WINDCHILL (B)(4) ON 17JUL2024, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE B(ABO2) REACTIONS IN ABO FORWARD TYPING FOR 5 DONORS USING MTS AB MONOCLONAL GROUPING CARD LOTS 102023057-03 AND 102023057-06 IN MANUAL METHOD. DATES OF EVENTS: 12,15 AND 16JUL2024 AWARENESS DATE: 17JUL2024 COMPLAINANT/COMPLAINT REPORTER: (B)(6), MEDICAL TECHNOLOGIST REPORTED ON 17JUL2024 BY THE CUSTOMER TO THE ORTHO GTSC. REAGENTS: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03, EXPIRY 16OCT2024; MANUFACTURED 16JAN2024 MTS AB MONOCLONAL GROUPING CARD LOT 102023057-06, EXPIRY 04DEC2024; MANUFACTURED 04MAR2024 DONOR INFORMATION: 5 DIFFERENT DONORS, ALL BLOOD TYPE A(ABO1) THE CUSTOMER REPORTED THAT, ON 12,15 AND 16JUL2024, THEY HAD TESTED SAMPLES FROM 5 DONORS KNOWN TO BE BLOOD GROUP A(ABO1) FOR ABO FORWARD TYPING USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-03 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED A VARIETY OF REACTIONS: A MIXED FIELD (MF) REACTION WAS OBTAINED FOR 1 UNIT, POSITIVE 2+ REACTIVITY WAS OBTAINED FOR 2 UNITS, AND POSITIVE 3+ REACTIVITY WAS OBTAINED FOR 2 UNITS WITH THE MTS ANTI-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967656 ↗
• MalfunctionAug 9, 2024False Positive Result; False Positive Result

  REPORT 2 OF 2 CMS 2637062, WINDCHILL (B)(4) COMPLAINT DESCRIPTION: ON 16JUL2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT FALSE POSITIVE RESULTS OF THE ANTI-B TYPING FOR TWO DONOR UNITS USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-04 (EXPIRY 05NOV2024) IN MANUAL GEL METHOD. CUSTOMER NAME: (B)(6), EVENT DATE: 12JUL2024 AND 13JUL2024, REPORTED 16JUL2024. REAGENT: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-04 (EXPIRY 05NOV2024, MANUFACTURED 05FEB2024) MANUAL METHOD USING ORTHO WORKSTATION ID-MTS (SERIAL (B)(6). DONOR UNIT IDS PROVIDED BY CUSTOMER: 602 AND 846; BOTH UNITS WERE KNOWN TO BE "A" UNITS. THE CUSTOMER REPORTED THAT ON 12JUL2024, TWO DONOR UNITS WERE TESTED IN MANUAL GEL METHOD UTILIZING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-04, AND RESULTS DISPLAYED A DISCREPANT FORWARD TYPE OF AB WITH FALSE POSITIVE REACTIONS IN THE ANTI-B COLUMNS. THESE RESULTS DID NOT CORRELATE WITH THE EXPECTED RESULTS OF BLOOD GROUP "A" FOR THE UNITS. THE FOLLOWING DAY, 13JUL2024, A DIFFERENT TECHNOLOGIST AT THE CUSTOMER SITE TESTED THE SAME DONOR UNITS IN MANUAL GEL FOR AB GROUPING UTILIZING THE SAME MTS AB MONOCLONAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947364 ↗
• MalfunctionAug 8, 2024False Positive Result; False Positive Result

  REPORT 1 OF 2 CMS (B)(4), WINDCHILL RA607026. COMPLAINT DESCRIPTION: ON 16JUL2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT FALSE POSITIVE RESULTS OF THE ANTI-B TYPING FOR TWO DONOR UNITS USING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-04 (EXPIRY 05NOV2024) IN MANUAL GEL METHOD. (B)(6). EVENT DATE: (B)(6) 2024 AND (B)(6) 2024, REPORTED 16JUL2024. REAGENT: MTS AB MONOCLONAL GROUPING CARD LOT 102023057-04 (EXPIRY 05NOV2024, MANUFACTURED 05FEB2024) MANUAL METHOD USING ORTHO WORKSTATION ID-MTS (SERIAL (B)(6)). DONOR UNIT IDS PROVIDED BY CUSTOMER: (B)(6); BOTH UNITS WERE KNOWN TO BE "A" UNITS. THE CUSTOMER REPORTED THAT ON (B)(6) 2024, TWO DONOR UNITS WERE TESTED IN MANUAL GEL METHOD UTILIZING MTS AB MONOCLONAL GROUPING CARD LOT 102023057-04, AND RESULTS DISPLAYED A DISCREPANT FORWARD TYPE OF AB WITH FALSE POSITIVE REACTIONS IN THE ANTI-B COLUMNS. THESE RESULTS DID NOT CORRELATE WITH THE EXPECTED RESULTS OF BLOOD GROUP "A" FOR THE UNITS. THE FOLLOWING DAY, (B)(6) 2024 , A DIFFERENT TECHNOLOGIST AT THE CUSTOMER SITE TESTED THE SAME DONOR UNITS IN MANUAL GEL FOR AB GROUPING UTILIZING THE SAME MTS AB MONOCLONAL GROUPIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939856 ↗