MTS MTS081115Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10758750005963), received between Jul 12, 2023 and Apr 28, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025False Negative Result; False Negative Result

  CMS (B)(4) ON (B)(6) 2025, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT A FALSE NEGATIVE RESULT FOR ONE PATIENT SAMPLE ON THE ANTI-A COLUMN FOR ABO FORWARD GROUPING TESTING USING MTS A/B/D MONOCLONAL GROUPING CARD LOT 081624053-09(EXPIRY DATE: 05AUG2025) ON THEIR ORTHO VISION ID-MTS ANALYZER ((B)(6)). COMPLAINANT: (B)(6) LABORATORY SUPERVISOR. EVENT DATE: 10APR2025, AWARENESS DATE: 11APR2025. ORTHO VISION ID-MTS (B)(6) INSTALL DATE: 22MAY2020, SW VERSION: 5.16.0 REAGENTS: MTS A/B/D MONOCLONAL GROUPING CARD LOTS: 081624053-09, EXPIRY DATE: 05AUG2025, MANUFACTURE DATE: 05NOV2024, 110124053-04, EXPIRY DATE: 03SEP2025, MANUFACTURE DATE: 03DEC2024 MTS A/B/D AND REVERSE GROUPING CARD LOT: 112124037-15, EXPIRY DATE: 09OCT2025, MANUFACTURE DATE: 09JAN2025 MTS DILUENT 2 PLUS: MDP250, EXPIRY DATE: 23JAN2026 SAMPLE INFORMATION: 34YR OLD FEMALE, 10 WEEKS PREGNANT, WITH NO PREVIOUS HISTORY OF BLOOD GROUP OR TRANSFUSIONS. SAMPLE (B)(6), ENCRYPTED SAMPLE ID: (B)(6) ON (B)(6) 2025, THE CUSTOMER LOADED ONE PATIENT SAMPLE ONTO THE ORTHO VISION ID-MTS ANALYZER ((B)(4)). THE SAMPLE WAS THEN TESTED FOR ABO-RH IN MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 112124037

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921128 ↗
• MalfunctionMar 28, 2025False Positive Result; False Positive Result

  CMS (B)(4), WINDCHILL RA609435 ON (B)(6) 2025, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS A DISCREPANT FALSE POSITIVE RESULT OF THE ANTI-B TYPING FOR ONE DONOR UNIT USING MTS ABD MONOCLONAL GROUPING CARD LOT 110124053-02 (EXPIRY 02SEP2025) ON THEIR ORTHO VISION ID-MTS (SERIAL (B)(6). CUSTOMER NAME: (B)(6), MEDICAL TECHNOLOGIST (B)(6); (B)(6) CUSTOMER# (B)(6) EVENT DATE: 18MAR2025, REPORTED SAME DAY. REAGENT: MTS ABD MONOCLONAL GROUPING CARD LOT 110124053-02 (EXPIRY 02SEP2025, MANUFACTURED 02DEC2024) MTS DILUENT 2 PLUS LOT MD242 (EXPIRY 07OCT2025) AUTOMATED METHOD USING ORTHO VISION ID-MTS (SERIAL (B)(6) TRADITIONAL TUBE METHOD (REAGENT DETAILS NOT PROVIDED) DONOR UNIT ID: (B)(6) (ENCRYPTED ID: F1-34-D5-C2-FA-46-3F-D3-90-4E-7F-91-ED-79-CF-A9-07-56-67-0B-D3-E4-75-DC-EF-A6-74-33-B4-3D-EC-9F) KNOWN TO BE A BLOOD GROUP A POSITIVE UNIT. THE CUSTOMER REPORTED THAT ON (B)(6) 2025, ONE DONOR UNIT WAS TESTED IN AUTOMATED METHOD UTILIZING MTS ABD MONOCLONAL GROUPING CARD LOT 110124053-02, AND RESULTS DISPLAYED A DISCREPANT FORWARD TYPE OF AB POSITIVE WITH A FALSE POSITIVE REACTION IN THE ANTI-B COLUMN. THESE RESULTS DID NOT CORRELATE WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721720 ↗
• MalfunctionJan 8, 2025False Negative Result; False Negative Result

  CMS (B)(4), WINDCHILL (B)(4) ON (B)(6) 2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT FALSE NEGATIVE RESULTS FOR ONE DONOR UNIT WHEN PERFORMING ABO UNIT CONFIRMATION TYPING UTILIZING MTS ABD MONOCLONAL GROUPING CARD LOT, 081624053-03, IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER ( SERIAL (B)(6) ), COMPLAINANT: (B)(6). DATE OF EVENT: 05DEC2024, (REPORTED 10DEC2024), REAGENT: MTS ABO MONOCLONAL GROUPING LOT 081624053-03, EXPIRY 26MAY2025, MANUFACTURED 26AUG2024, DONOR INFORMATION: ONE DONOR UNIT LABELED A POSITIVE. UNIT ID: (B)(6), THE CUSTOMER REPORTED THAT ON (B)(6) 2024, THEY TESTED ONE DONOR UNIT FOR ABO UNIT CONFIRMATION TYPING USING MTS ABD MONOCLONAL GROUPING CARD LOT, 081624053-03, IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER AND THAT AN UNEXPECTED NEGATIVE REACTION FOR ANTI-A COLUMN WAS OBTAINED AND AN ABO FORWARD TYPE OF O POSITIVE WAS PRODUCED. ON THE SAME DAY, THE CUSTOMER RETESTED THE UNIT IN MANUAL TUBE METHOD AND OBTAINED AN ABO FORWARD TYPE OF O POSITIVE. NO FURTHER DETAILS WERE PROVIDED. THE CUSTOMER STATED THEY RETURNED THE UNIT TO THEIR BLOOD SUPPLIER, VITALANT, AND THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100004 ↗
• MalfunctionJun 25, 2024False Negative Result; False Negative Result

  CMS#2624069 WINDCHILL RA606416 ON 28MAY2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT FALSE NEGATIVE RESULTS OF THE ANTI-A TYPING FOR ONE DONOR UNIT USING MTS ABD MONOCLONAL GROUPING CARD LOT 10042353-06 (EXPIRY 17OCT2024) IN COMBINATION WITH THEIR ORTHO VISION ID-MTS ANALYZER (SERIAL (B)(6)). CUSTOMER NAME: (B)(6), MEDICAL TECHNOLOGIST +(B)(6), EVENT DATE: 28MAY2024, REPORTED SAME DAY. REAGENTS: MTS ABD MONOCLONAL GROUPING CARD LOT 100423053-06 (EXPIRY 17OCT2024, MANUFACTURED 17JAN2024) ORTHO ANTI-A LOT BAA633A (EXPIRY 15NOV2025) DONOR INFORMATION: UNIT ID - (B)(6) UNIT WAS RECEIVED AT CUSTOMER SITE LABELED AS B NEGATIVE FROM DONOR CENTER. CUSTOMER REPORTED THAT ON (B)(6) 2024, THE DONOR UNIT WAS TESTED IN MANUAL TUBE METHOD AND RESULTS DISPLAYED AS AB NEGATIVE WITH REACTIONS OF 2+ FOR ANTI-A(LOT BAA633A) AND 4+ FOR ANTI-B(LOT INFORMATION NOT PROVIDED). THESE RESULTS DID NOT CORRELATE WITH THE EXPECTED RESULTS FOR THE B NEGATIVE LABEL ON THE UNIT. ON THE SAME DAY, THE CUSTOMER TESTED THE SAME DONOR UNIT SEGMENT ON THE ORTHO VISION ((B)(6)) FOR ABD GROUPING UTILIZING MTS ABD MONOCLONAL GROUPING CARD LOT 100423053-0

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607717 ↗
• MalfunctionApr 25, 2024False Positive Result; False Positive Result

  REPORT 2 OF 2 CMS 2609581 WINDCHILL RA605915 COMPLAINT DESCRIPTION: ON (B)(6) 024, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT FALSE POSITIVE RESULTS FOR THE ANTI-B AND ANTI-D COLUMNS FOR ABO FORWARD GROUPING TESTING OF TWO KNOWN O NEGATIVE DONOR UNITS IN MTS ABD MONOCLONAL GROUPING CARD LOT 081823053-02 (EXPIRY 22MAY2024) USING MANUAL GEL TECHNIQUE. COMPLAINANT: (B)(6) (MEDICAL TECHNOLOGIST) (B)(6) 62276 DATE OF EVENTS: ORIGINAL DATE REQUESTED, BUT NOT PROVIDED AND 01APR2024; REPORTED 01APR2024. REAGENTS: MTS ABD MONOCLONAL GROUPING GEL CARD LOT 081823053-02 (EXPIRY: 22MAY2024) MTS 2 PLUS DILUENT (LOT INFORMATION REQUESTED BUT NOT PROVIDED) SAMPLE INFORMATION: 2 DONOR SEGMENTS - EXPECTED O NEG SAMPLE IDS REQUESTED BUT NOT PROVIDED. THE CUSTOMER STATED THAT ON (B)(6) 2024, ONE DONOR UNIT SEGMENT WAS TESTED FOR ABO USING ABD MONOCLONAL GROUPING GEL CARD LOT 081823053-02. THE UNIT SAMPLE PRODUCED UNEXPECTED POSITIVE 3+ REACTIONS IN THE ANTI-B AND ANTI-D COLUMNS OF THE GEL CARD. THE CUSTOMER STATES THAT THE WEEK PRIOR, A SIMILAR EVENT ALSO OCCURRED WITH FALSE POSITIVE 3+ REACTIONS IN BOTH THE ANTI-B AND ANTI-D COLUMNS FOR ONE O NEGATIVE DONOR UTILIZING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181135 ↗
• MalfunctionApr 24, 2024False Positive Result; False Positive Result

  REPORT 1 OF 2 CMS 2609581 WINDCHILL RA605915 COMPLAINT DESCRIPTION: ON (B)(6) 2024, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT FALSE POSITIVE RESULTS FOR THE ANTI-B AND ANTI-D COLUMNS FOR ABO FORWARD GROUPING TESTING OF TWO KNOWN O NEGATIVE DONOR UNITS IN MTS ABD MONOCLONAL GROUPING CARD LOT 081823053-02 (EXPIRY 22MAY2024) USING MANUAL GEL TECHNIQUE. COMPLAINANT: (B)(6) DATE OF EVENTS: ORIGINAL DATE REQUESTED, BUT NOT PROVIDED AND (B)(6) 2024; REPORTED (B)(6) 2024. REAGENTS: MTS ABD MONOCLONAL GROUPING GEL CARD LOT 081823053-02 (EXPIRY: 22MAY2024) MTS 2 PLUS DILUENT (LOT INFORMATION REQUESTED BUT NOT PROVIDED) SAMPLE INFORMATION: 2 DONOR SEGMENTS - EXPECTED O NEG SAMPLE IDS REQUESTED BUT NOT PROVIDED. THE CUSTOMER STATED THAT ON (B)(6) 2024, ONE DONOR UNIT SEGMENT WAS TESTED FOR ABO USING ABD MONOCLONAL GROUPING GEL CARD LOT 081823053-02. THE UNIT SAMPLE PRODUCED UNEXPECTED POSITIVE 3+ REACTIONS IN THE ANTI-B AND ANTI-D COLUMNS OF THE GEL CARD. THE CUSTOMER STATES THAT THE WEEK PRIOR, A SIMILAR EVENT ALSO OCCURRED WITH FALSE POSITIVE 3+ REACTIONS IN BOTH THE ANTI-B AND ANTI-D COLUMNS FOR ONE O NEGATIVE DONOR UTILIZING THE SAME MTS GEL CARD LOT. (THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172330 ↗
• MalfunctionDec 19, 2023False Positive Result; False Positive Result

  CMS#2575215, WINDCHILL# RA604272 A CUSTOMER COMPLAINED TO THE ORTHO GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR A PATIENT USING ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 041423053-01 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (50002741). COMPLAINANT/COMPLAINT REPORTER: HEIDIE BRUNETTI ¿ MEDICAL TECHNOLOGIST DATE OF EVENTS: 21 NOVEMBER 2023 REPORTED ON: 21 NOVEMBER 2023 BY HEIDIE BRUNETTI WHO REPORTED IT TO THE ORTHOCARE HELPDESK ON THE SAME DAY REAGENTS: ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 041423053-01 EXPIRY DATE 17 JANUARY 2024 MANUFACTURE DATE 17 APRIL 2023 SOFTWARE VERSION: 5.14.5 PATIENT INFORMATION: HISTORY OF BEING D(RH1) NEGATIVE AT THIS FACILITY AND ANOTHER FACILITY. THE CUSTOMER REPORTED THAT ON 21 NOVEMBER 2023, THEY HAD TESTED A PATIENT SAMPLE FOR D(RH1) TYPING USING ORTHO MTS A/B/D MONOCLONAL GROUPING CARD LOT 041423053-01 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (50002741) AND THAT THEY HAD OBTAINED POSITIVE REACTIONS (3+ REACTION STRENGTH) ON TWO OCCASIONS. THE CUSTOMER REPORTED THAT THEY HAD TESTED A SAMPLE FROM THIS PATIENT FOR D(RH1) TYPING IN TUB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355878 ↗
• MalfunctionDec 11, 2023False Positive Result; False Positive Result

  CMS (B)(4) WINDCHILL RA604262 (REPORT 2 OF 2) ON (B)(6) 2023, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT FALSE POSITIVE RESULTS FOR ANTI-B OF THE FORWARD GROUPING TEST IN MTS ABD/ABD MONOCLONAL GEL CARD LOT 041423053-03 (EXPIRY 19MAR2024) FOR ONE PATIENT AND ONE DONOR SAMPLE USING MANUAL GEL TECHNIQUE. COMPLAINANT: (B)(6) (MEDICAL TECHNOLOGIST) (B)(6); (B)(6) CUSTOMER# (B)(6)HOSPITAL,(B)(6), DATE OF EVENTS: 13NOV2023, REPORTED SAME DAY. REAGENT: MTS ABD MONOCLONAL GEL CARD LOT 041423053-03 (EXPIRY: 19MAR2024) SAMPLE INFORMATION: DONOR ABO RETYPE ¿ KNOWN A POSITIVE UNIT PATIENT ABO RETYPE ¿ KNOWN A POSITIVE PATIENT HISTORY SAMPLE IDS NOT PROVIDED. THE CUSTOMER STATED THAT ON (B)(6) 2023, ONE PATIENT SAMPLE AND ONE DONOR UNIT WERE TESTED FOR ABO RETYPE USING ABD/ABD MONOCLONAL GEL CARD LOT 041423053-03. BOTH THE PATIENT SAMPLE AND THE DONOR UNIT PRODUCED UNEXPECTED POSITIVE 3+ REACTIONS IN THE B WELLS OF THEIR RESPECTIVE GEL CARDS. THE CUSTOMER IDENTIFIED THAT THE OPERATOR HAD NOT PERFORMED A VISUAL INSPECTION OF THE CARDS PRIOR TO USE. ONCE DISCREPANT RESULTS WERE OBTAINED, THE SLEEVE OF CARDS WAS FURTHER INSPECTED, AND IT WAS FOUND THAT THE CARDS UT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299789 ↗
• MalfunctionDec 11, 2023False Positive Result; False Positive Result

  CMS 2573270 WINDCHILL RA604262 (REPORT 1 OF 2) ON 13NOV2023, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT FALSE POSITIVE RESULTS FOR ANTI-B OF THE FORWARD GROUPING TEST IN MTS ABD/ABD MONOCLONAL GEL CARD LOT 041423053-03 (EXPIRY 19MAR2024) FOR ONE PATIENT AND ONE DONOR SAMPLE USING MANUAL GEL TECHNIQUE. COMPLAINANT: (B)(6). DATE OF EVENTS: 13NOV2023, REPORTED SAME DAY. REAGENT: MTS ABD MONOCLONAL GEL CARD LOT 041423053-03 (EXPIRY: 19MAR2024) SAMPLE INFORMATION: DONOR ABO RETYPE ¿ KNOWN A POSITIVE UNIT PATIENT ABO RETYPE ¿ KNOWN A POSITIVE PATIENT HISTORY SAMPLE IDS NOT PROVIDED. THE CUSTOMER STATED THAT ON 13NOV2023, ONE PATIENT SAMPLE AND ONE DONOR UNIT WERE TESTED FOR ABO RETYPE USING ABD/ABD MONOCLONAL GEL CARD LOT 041423053-03. BOTH THE PATIENT SAMPLE AND THE DONOR UNIT PRODUCED UNEXPECTED POSITIVE 3+ REACTIONS IN THE B WELLS OF THEIR RESPECTIVE GEL CARDS. THE CUSTOMER IDENTIFIED THAT THE OPERATOR HAD NOT PERFORMED A VISUAL INSPECTION OF THE CARDS PRIOR TO USE. ONCE DISCREPANT RESULTS WERE OBTAINED, THE SLEEVE OF CARDS WAS FURTHER INSPECTED, AND IT WAS FOUND THAT THE CARDS UTILIZED IN TESTING HAD NO LIQUID ABOVE THE GEL LAYER OF THE B COLUMN. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299784 ↗
• MalfunctionNov 7, 2023False Positive Result; False Positive Result

  (B)(4). A CUSTOMER CONTACTED ORTHO¿S GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) ON 11OCT2023, AFTER OBSERVING WHAT WAS DESCRIBED AS FALSE POSITIVE RESULTS IN THE ANTI-D COLUMN WHEN TESTING ONE NEWBORN CORD BLOOD SAMPLE FOR D(RH) ANTIGEN USING MTS ABD MONOCLONAL GEL CARD LOT 010623053-07 AND MTS ABD MONOCLONAL AND REVERSE CARD. LOT 051823037-04, IN CONJUNCTION WITH THEIR ORTHO VISION ANALYZER (50002990). DATE OF EVENTS: (B)(6), REPORTED: 11OCT2023 REPORTER: (B)(6), METHOD: AUTOMATION ¿ ORTHO VISION MTS 50002990 (MANUFACTURE DATE: 14DEC2018) REAGENTS: MTS081115 MTS ABD/ABD MONOCLONAL GROUPING CARD LOT 010623053-07, EXPIRY 21DEC2023, MANUFACTURE: 21MAR2023. MTS080515 MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 051823037-04 EXPIRY 07MAR2024, MANUFACTURE 07JUN2023. NO BIASED RESULTS WERE REPORTED TO THE PHYSICIANS AS RESULTS WERE QUESTIONED BY THE HEALTHCARE PROFESSIONAL WHEN MIXED FIELD RESULTS WERE OBTAINED. NEWBORN INFORMATION: NOT TRANSFUSED. RHD ANTIGEN TYPING MF AND 3+ ON VISION, NEGATIVE IN TUBE. NEWBORN CORD SAMPLE ID: (B)(6), ENCRYPTED BABY SAMPLE ID: (B)(6). MOTHER INFORMATION: NOT TRANSFUSED. MOTHER SAMPLE ID: (B)(6). ENCRYPTED MOM SAMPLE ID: (B)(6), HISTORICAL RHD NEGATIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083010 ↗
• MalfunctionJul 12, 2023False Negative Result; False Negative Result

  MXP2533839 RA602498 COMPLAINT DESCRIPTION ¿ ONE CUSTOMER CONTACTED ORTHO TSC TO REPORT SIX DONOR SAMPLES PRODUCING DISCREPANT FALSE NEGATIVE AND FALSE POSITIVE RESULTS WITH MTS ABD/ABD MONOCLONAL GEL CARD LOT 010623053-06 (EXPIRY 14NOV2023) USING THE ORTHO VISION MTS ANALYZER (SERIAL#(B)(6)). THE CUSTOMER HAD EXPECTED REACTIONS FOR SEVEN DONOR SAMPLES, BUT DISCREPANT RESULTS WERE OBSERVED IN VARIOUS A, B AND D MICROTUBES OF SIX SAMPLES. DONOR SAMPLES: (B)(6): EXPECTED ONEG ¿ OBSERVED A 1+ REACTION IN D MICROTUBE; OPOS INTERPRETATION. (B)(6): EXPECTED ONEG ¿ OBSERVED IND(?) IN A MICROTUBE AND 1+ IN B MICROTUBE; ¿?¿ NEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED A NEG ¿ OBSERVED 0 REACTION IN A MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED A POS ¿ OBSERVED IND(?) IN A MICROTUBE; ¿?¿POS INTERPRETATION. ONE ADDITIONAL SAMPLE WAS REPORTED BY THE CUSTOMER THAT PRODUCED VALID INTERPRETATIONS, BUT REACTION STRENGTH WAS DECREASED FROM EXPECTED WHEN USING THE CARD LOT UNDER INVESTIGATION. (B)(6): EXPECTED A NEG ¿ 1+ REACTION IN A MICROTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306986 ↗
• MalfunctionJul 12, 2023False Negative Result; False Negative Result

  MXP2533839 RA602498 COMPLAINT DESCRIPTION ¿ ONE CUSTOMER CONTACTED ORTHO TSC TO REPORT SIX DONOR SAMPLES PRODUCING DISCREPANT FALSE NEGATIVE AND FALSE POSITIVE RESULTS WITH MTS ABD/ABD MONOCLONAL GEL CARD LOT 010623053-06 (EXPIRY 14NOV2023) USING THE ORTHO VISION MTS ANALYZER (SERIAL#(B)(6)). THE CUSTOMER HAD EXPECTED REACTIONS FOR SEVEN DONOR SAMPLES, BUT DISCREPANT RESULTS WERE OBSERVED IN VARIOUS A, B AND D MICROTUBES OF SIX SAMPLES. DONOR SAMPLES: (B)(6): EXPECTED ONEG ¿ OBSERVED A 1+ REACTION IN D MICROTUBE; OPOS INTERPRETATION. (B)(6): EXPECTED ONEG ¿ OBSERVED IND(?) IN A MICROTUBE AND 1+ IN B MICROTUBE; ¿?¿ NEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED A NEG ¿ OBSERVED 0 REACTION IN A MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED A POS ¿ OBSERVED IND(?) IN A MICROTUBE; ¿?¿POS INTERPRETATION. ONE ADDITIONAL SAMPLE WAS REPORTED BY THE CUSTOMER THAT PRODUCED VALID INTERPRETATIONS, BUT REACTION STRENGTH WAS DECREASED FROM EXPECTED WHEN USING THE CARD LOT UNDER INVESTIGATION. (B)(6): EXPECTED A NEG ¿ 1+ REACTION IN A MICROTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306805 ↗
• MalfunctionJul 12, 2023False Negative Result; False Negative Result

  MXP2533839 RA602498 COMPLAINT DESCRIPTION ¿ ONE CUSTOMER CONTACTED ORTHO TSC TO REPORT SIX DONOR SAMPLES PRODUCING DISCREPANT FALSE NEGATIVE AND FALSE POSITIVE RESULTS WITH MTS ABD/ABD MONOCLONAL GEL CARD LOT 010623053-06 (EXPIRY 14NOV2023) USING THE ORTHO VISION MTS ANALYZER (SERIAL#(B)(6)). THE CUSTOMER HAD EXPECTED REACTIONS FOR SEVEN DONOR SAMPLES, BUT DISCREPANT RESULTS WERE OBSERVED IN VARIOUS A, B AND D MICROTUBES OF SIX SAMPLES. DONOR SAMPLES: (B)(6): EXPECTED ONEG ¿ OBSERVED A 1+ REACTION IN D MICROTUBE; OPOS INTERPRETATION. (B)(6): EXPECTED ONEG ¿ OBSERVED IND(?) IN A MICROTUBE AND 1+ IN B MICROTUBE; ¿?¿ NEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED A NEG ¿ OBSERVED 0 REACTION IN A MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED A POS ¿ OBSERVED IND(?) IN A MICROTUBE; ¿?¿POS INTERPRETATION. ONE ADDITIONAL SAMPLE WAS REPORTED BY THE CUSTOMER THAT PRODUCED VALID INTERPRETATIONS, BUT REACTION STRENGTH WAS DECREASED FROM EXPECTED WHEN USING THE CARD LOT UNDER INVESTIGATION. (B)(6): EXPECTED A NEG ¿ 1+ REACTION IN A MICROTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306666 ↗
• MalfunctionJul 12, 2023False Negative Result; False Negative Result

  MXP2533839 RA602498 COMPLAINT DESCRIPTION ¿ ONE CUSTOMER CONTACTED ORTHO TSC TO REPORT SIX DONOR SAMPLES PRODUCING DISCREPANT FALSE NEGATIVE AND FALSE POSITIVE RESULTS WITH MTS ABD/ABD MONOCLONAL GEL CARD LOT 010623053-06 (EXPIRY 14NOV2023) USING THE ORTHO VISION MTS ANALYZER (SERIAL#(B)(6)). THE CUSTOMER HAD EXPECTED REACTIONS FOR SEVEN DONOR SAMPLES, BUT DISCREPANT RESULTS WERE OBSERVED IN VARIOUS A, B AND D MICROTUBES OF SIX SAMPLES. DONOR SAMPLES: (B)(6): EXPECTED ONEG ¿ OBSERVED A 1+ REACTION IN D MICROTUBE; OPOS INTERPRETATION. (B)(6): EXPECTED ONEG ¿ OBSERVED IND(?) IN A MICROTUBE AND 1+ IN B MICROTUBE; ¿?¿ NEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED A NEG ¿ OBSERVED 0 REACTION IN A MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED A POS ¿ OBSERVED IND(?) IN A MICROTUBE; ¿?¿POS INTERPRETATION. ONE ADDITIONAL SAMPLE WAS REPORTED BY THE CUSTOMER THAT PRODUCED VALID INTERPRETATIONS, BUT REACTION STRENGTH WAS DECREASED FROM EXPECTED WHEN USING THE CARD LOT UNDER INVESTIGATION. (B)(6): EXPECTED A NEG ¿ 1+ REACTION IN A MICROTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306241 ↗
• MalfunctionJul 12, 2023False Negative Result; False Negative Result

  (B)(4) COMPLAINT DESCRIPTION ¿ ONE CUSTOMER CONTACTED ORTHO TSC TO REPORT SIX DONOR SAMPLES PRODUCING DISCREPANT FALSE NEGATIVE AND FALSE POSITIVE RESULTS WITH MTS ABD/ABD MONOCLONAL GEL CARD LOT 010623053-06 (EXPIRY 14NOV2023) USING THE ORTHO VISION MTS ANALYZER (SERIAL#(B)(6)). THE CUSTOMER HAD EXPECTED REACTIONS FOR SEVEN DONOR SAMPLES, BUT DISCREPANT RESULTS WERE OBSERVED IN VARIOUS A, B AND D MICROTUBES OF SIX SAMPLES. DONOR SAMPLES: (B)(6) : EXPECTED ONEG ¿ OBSERVED A 1+ REACTION IN D MICROTUBE; OPOS INTERPRETATION. (B)(6) : EXPECTED ONEG ¿ OBSERVED IND(?) IN A MICROTUBE AND 1+ IN B MICROTUBE; ¿?¿ NEG INTERPRETATION. (B)(6) : EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6) : EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6) : EXPECTED A NEG ¿ OBSERVED 0 REACTION IN A MICROTUBE; ONEG INTERPRETATION. (B)(6) : EXPECTED A POS ¿ OBSERVED IND(?) IN A MICROTUBE; ¿?¿POS INTERPRETATION. ONE ADDITIONAL SAMPLE WAS REPORTED BY THE CUSTOMER THAT PRODUCED VALID INTERPRETATIONS, BUT REACTION STRENGTH WAS DECREASED FROM EXPECTED WHEN USING THE CARD LOT UNDER INVESTIGATION. (B)(6) : EXPECTED A NEG ¿ 1+ REACTION IN A MICROTUBE, RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306147 ↗
• MalfunctionJul 12, 2023False Negative Result; False Negative Result

  (B)(4) COMPLAINT DESCRIPTION ¿ ONE CUSTOMER CONTACTED ORTHO TSC TO REPORT SIX DONOR SAMPLES PRODUCING DISCREPANT FALSE NEGATIVE AND FALSE POSITIVE RESULTS WITH MTS ABD/ABD MONOCLONAL GEL CARD LOT 010623053-06 (EXPIRY 14NOV2023) USING THE ORTHO VISION MTS ANALYZER (SERIAL#(B)(6)). THE CUSTOMER HAD EXPECTED REACTIONS FOR SEVEN DONOR SAMPLES, BUT DISCREPANT RESULTS WERE OBSERVED IN VARIOUS A, B AND D MICROTUBES OF SIX SAMPLES. DONOR SAMPLES: (B)(6): EXPECTED ONEG ¿ OBSERVED A 1+ REACTION IN D MICROTUBE; OPOS INTERPRETATION. (B)(6): EXPECTED ONEG ¿ OBSERVED IND(?) IN A MICROTUBE AND 1+ IN B MICROTUBE; ¿?¿ NEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED B NEG ¿ OBSERVED 0 REACTION IN B MICROTUBE; ONEG INTERPRETATION. (B)(6): EXPECTED A NEG ¿ OBSERVED 0 REACTION IN A MICROTUBE; ONEG INTERPRETATION. (B)(6) : EXPECTED A POS ¿ OBSERVED IND(?) IN A MICROTUBE; ¿?¿POS INTERPRETATION. ONE ADDITIONAL SAMPLE WAS REPORTED BY THE CUSTOMER THAT PRODUCED VALID INTERPRETATIONS, BUT REACTION STRENGTH WAS DECREASED FROM EXPECTED WHEN USING THE CARD LOT UNDER INVESTIGATION. (B)(6): EXPECTED A NEG ¿ 1+ REACTION IN A MICROTUBE, REPEAT 3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305466 ↗