MTS MTS084024Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10758750005994), received between Jan 9, 2023 and Apr 10, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026False Negative Result

  CMS 100853550 AND 100859186 / RA614056 COMPLAINT DESCRIPTION: ON (B)(6) 2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE REACTIONS IN DIRECT AGGLUTINATION TESTING (DAT) FOR A NEWBORN CORD BLOOD SAMPLE USING MTS ANTI-IGG CARD LOTS: 110825001-10 AND 110825001-13 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZERS: (B)(4) EQUIPPED WITH SOFTWARE VERSION 5.16.0. DATE OF EVENTS: 16 AND 18 MARCH 2026 AWARENESS DATE: 18 MARCH 2026 COMPLAINANT/COMPLAINT REPORTER: (B)(6) - LABORATORY SUPERVISOR REAGENTS: MTS ANTI-IGG CARD LOT: 110825001-10, EXPIRY 02 SEPTEMBER 2026; MANUFACTURED 02 DECEMBER 2025 MTS ANTI-IGG CARD LOT: 110825001-13, EXPIRY 05 SEPTEMBER 2026; MANUFACTURED 05 DECEMBER 2025 OTHER REAGENTS: ANTI-HUMAN GLOBULIN (RABBIT AND MURINE MONOCLONAL) BIOCLONE ANTI-IGG, C3D; POLYSPECIFIC (CLEAR) LOT: RM480E1, EXPIRY 08 OCTOBER 2026, MANUFACTURED 08 OCTOBER 2025 ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (CLEAR) LOT: IG188D, EXPIRY 30 JULY 2026; MANUFACTURED 30 JULY 2024 PATIENT HISTORY: NEWBORN, BLOOD GROUP A(ABO1) RHD POSITIVE MOTHER IS BLOOD GROUP O RHD POSITIVE, NEGATIVE ANTIBODY SCREEN THE CUSTOMER REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844142 ↗
• MalfunctionApr 10, 2026False Negative Result

  (B)(4). COMPLAINT DESCRIPTION: ON 18 MARCH 2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE REACTIONS IN DIRECT AGGLUTINATION TESTING (DAT) FOR A NEWBORN CORD BLOOD SAMPLE USING MTS ANTI-IGG CARD LOTS 110825001-10 AND 110825001-13 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZERS (B)(6) EQUIPPED WITH SOFTWARE VERSION 5.16.0. DATE OF EVENTS: (B)(6) 2026. AWARENESS DATE: 18 MARCH 2026. COMPLAINANT/COMPLAINT REPORTER: (B)(6) - LABORATORY SUPERVISOR REAGENTS: MTS ANTI-IGG CARD LOT 110825001-10, EXPIRY 02 SEPTEMBER 2026; MANUFACTURED 02 DECEMBER 2025 MTS ANTI-IGG CARD LOT 110825001-13, EXPIRY 05 SEPTEMBER 2026; MANUFACTURED 05 DECEMBER 2025 OTHER REAGENTS: ANTI-HUMAN GLOBULIN (RABBIT AND MURINE MONOCLONAL) BIOCLONE ANTI-IGG, C3D; POLYSPECIFIC (CLEAR) LOT RM480E1, EXPIRY 08 OCTOBER 2026, MANUFACTURED 08 OCTOBER 2025 ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (CLEAR) LOT IG188D, EXPIRY 30 JULY 2026; MANUFACTURED 30 JULY 2024 PATIENT HISTORY: NEWBORN, BLOOD GROUP A(ABO1) RHD POSITIVE MOTHER IS BLOOD GROUP O RHD POSITIVE, NEGATIVE ANTIBODY SCREEN THE CUSTOMER REPORTED THAT, ON (B)(6) 2026, THEY HAD TESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839133 ↗
• MalfunctionJan 7, 2026False Negative Result

  CMS (B)(4) / RA613063 A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER(GTSC) ON (B)(6) 2025 AFTER OBSERVING WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE RESULT FOR ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT USING ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD 071025001-06 EXPIRY DATE 04 MAY 2026 (MANUFACTURING DATE 04 AUGUST 2025) IN MANUAL MTS GEL TECHNIQUE (USING ORTHO WORKSTATION ID-MTS). COMPLAINANT/COMPLAINT REPORTER NAME AND POSITION: (B)(6), LABORATORY SUPERVISOR (B)(6) EVENT DATE: 05 DECEMBER 2025, REPORTED ON (B)(6) 2025 PATIENTS INFORMATION: FEMALE PREGNANT HAS RECEIVED A PROPHYLACTIC ANTI-D. EXPECTED TO HAVE A WEAK PASSIVE ANTI-D(RH1) ANTIBODY. NO FURTHER INFORMATION. REAGENT INFORMATION ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD 071025001-06 EXPIRY DATE 04 MAY 2026 (MANUFACTURE DATE 04 AUGUST 2025) OTHER REAGENTS INFORMATION: 0.8% SELECTOGEN LOT VS749 EXPIRY DATE 23 DECEMBER 2025 (MANUFACTURE DATE 21 OCTOBER 2025) MTS ANTI-IGG CARD LOT 062525001-03 EXPIRY DATE 09 APRIL 2026 (MANUFACTURE DATE 09 JULY 2025) MTS ANTI-IGG CARD LOT 062525001-11 EXPIRY DATE 13 MAY 2026 (MANUFACTURE DATE 13 AUGUST 2025) BACKGROUND INFORMATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989646 ↗
• MalfunctionNov 19, 2025False Negative Result; False Negative Result

  (B)(4) / RA612664 ON 30OCT2025, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT THEY TESTED ONE PATIENT SAMPLE FOR DAT USING MTS ANTI-IGG GEL CARD LOT 052025001-10 IN CONJUNCTION WITH THEIR ORTHO WORKSTATION ID-MTS, AND THAT THEY OBTAINED A DISCREPANT NEGATIVE RESULT. COMPLAINANT: (B)(6), MEDICAL TECHNOLOGIST(B)(6), (B)(6) EVENT DATE: 30OCT2025, REPORTED ON THE SAME DAY. ORTHO WORKSTATION ID-MTS, 510011120, INSTALL DATE: 20SEP2022 REAGENTS: MTS ANTI-IGG CARD LOT 052025001-10, EXPIRATION: 11APR2026, MANUFACTURE: 11JUL2025 MTS DILUENT 2 LOT MD197, EXPIRATION: 10APR2026, MANUFACTURE: 10APR2025 SAMPLE INFORMATION: FEMALE, NOT PREGNANT, NO PREVIOUS ANTIBODY HISTORY, NO RECENT TRANSFUSION HISTORY. THE CUSTOMER STATED THAT ONE PATIENT SAMPLE WAS TESTED IN MANUAL GEL METHOD USING THEIR ORTHO WORKSTATION ID-MTS (510011120) IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOT 052025001-10 AND MTS DILUENT 2 LOT MD197, WHICH RESULTED IN A NEGATIVE DAT TEST. THE CUSTOMER STATED THAT IT IS THEIR FACILITY POLICY TO TEST ALL FIRST-TIME RH-NEGATIVE PATIENTS FOR WEAK-D, AND IF THE RESULT IS POSITIVE, DAT TESTING IS SUBSEQUENTLY PERFORMED. SINCE THE PATIENT TESTED POSITIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594819 ↗
• MalfunctionSep 9, 2025False Negative Result; False Negative Result

  CMS 100436644 / RA611955 COMPLAINT DESCRIPTION: CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE REACTION FOR ONE CORD BLOOD SAMPLE FOR DAT USING MTS ANTI-IGG (RABBIT) GEL CARD LOT: 042825001-02 ON THEIR ORTHO VISION ID-MTS ANALYZER (50004102). DATE OF EVENT: 15 AUGUST 2025 REPORTED: 18 AUGUST 2025 REAGENTS: MTS ANTI-IGG CARD LOT: 042825001-02 EXPIRY DATE 28 FEBRUARY 2026, MANUFACTURED ON 28 MAY 2025 MTS DILUENT 2 LOT: MD197, EXPIRY DATE 10 APRIL 2026, MANUFACTURED ON 10 APRIL 2025 NEWBORN INFORMATION: NEWBORN SAMPLE ID: (B)(6). PATIENT ID: (B)(6). MOM BLOOD TYPE - O D (RH1) POSITIVE AND BABY BLOOD TYPE - B D (RH1) NEGATIVE THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THEY TESTED A NEWBORN SAMPLE FOR DAT TESTING ON ORTHO VISION ID-MTS ANALYZER (SERIAL NUMBER: (B)(6) WITH MTS ANTI-IGG CARD LOT: 042825001- 02 AND MTS DILUENT 2 LOT: MD197 AND THAT A NEGATIVE RESULT WAS OBTAINED AND REPORTED TO THE PHYSICIAN. THE CUSTOMER SAID THAT THE RESULTS WERE QUESTIONED BY THE NURSERY ON (B)(6) 2025 DUE TO THE BABY HAVING A JAUNDICE AND HYPERBILIRUBINEMIA WITH SIGNS OF HEMOLYTIC DISEASE OF THE NEWBORN. THE NURSERY ASKED THE CUST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006830 ↗
• MalfunctionMay 30, 2025False Negative Result; False Negative Result

  CMS (B)(4) WINDCHILL (B)(4) A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE MAJOR CROSSMATCH RESULTS IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PROFICIENCY SAMPLE AGAINST A DONOR SAMPLE USING ORTHO MTS ANTI-IGG CARD LOTS 090424001-04 AND 120624001-07 IN COMBINATION WITH THEIR ORTHO WORKSTATION ID-MTS ((B)(4)). COMPLAINANT/COMPLAINT REPORTER: (B)(6) DATE OF EVENTS: 03 APRIL AND 01 MAY 2025 REPORTED ON: 02 MAY 2025 BY (B)(6) TO ORTHO GTSC REAGENTS: ORTHO MTS ANTI-IGG CARD LOT 090424001-04, EXPIRY DATE 18 JUNE 2025, MANUFACTURE DATE 18 SEPTEMBER 2024; ORTHO MTS ANTI-IGG CARD, LOT 120624001-07, EXPIRY DATE 18 SEPTEMBER 2025, MANUFACTURE DATE 18 DECEMBER 2024, MTS DILUENT 2, LOT MD185, EXPIRY DATE 01 APRIL 2025. SAMPLE INFORMATION: PROFICIENCY SAMPLE: (B)(6); A D(RH1) POSITIVE DONOR SAMPLE: (B)(6); NO FURTHER INFORMATION WAS PROVIDED FOR DONOR BLOOD GROUP AND PHENOTYPE THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THEY HAD TESTED A PROFICIENCY SAMPLE ((B)(6)) FOR CROSSMATCH TESTING IN IAT AGAINST A DONOR SAMPLE ((B)(6)) USING ORTHO MTS ANTI-IGG CARD LOT 090424001-04 AND MTS DILUENT 2 LOT MD185 IN COMBINA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114791 ↗
• MalfunctionMay 30, 2025False Negative Result; False Negative Result

  CMS (B)(4) WINDCHILL RA609922 A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE MAJOR CROSSMATCH RESULTS IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PROFICIENCY SAMPLE AGAINST A DONOR SAMPLE USING ORTHO MTS ANTI-IGG CARD LOTS 090424001-04 AND 120624001-07 IN COMBINATION WITH THEIR ORTHO WORKSTATION ID-MTS (B)(4). COMPLAINANT/COMPLAINT REPORTER: (B)(6) - LABORATORY TECHNOLOGIST DATE OF EVENTS: 03 APRIL AND 01 MAY 2025 REPORTED ON: 02 MAY 2025 BY (B)(6) TO ORTHO GTSC REAGENTS: ORTHO MTS ANTI-IGG CARD LOT 090424001-04 EXPIRY DATE 18 JUNE 2025 MANUFACTURE DATE 18 SEPTEMBER 2024 ORTHO MTS ANTI-IGG CARD LOT 120624001-07 EXPIRY DATE 18 SEPTEMBER 2025 MANUFACTURE DATE 18 DECEMBER 2024 MTS DILUENT 2 LOT MD185 EXPIRY DATE 01 APRIL 2025 SAMPLE INFORMATION: PROFICIENCY SAMPLE: (B)(6); A D(RH1) POSITIVE DONOR SAMPLE:(B)(6); NO FURTHER INFORMATION WAS PROVIDED FOR DONOR BLOOD GROUP AND PHENOTYPE THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THEY HAD TESTED A PROFICIENCY SAMPLE (B)(6) FOR CROSSMATCH TESTING IN IAT AGAINST A DONOR SAMPLE (B)(6) USING ORTHO MTS ANTI-IGG CARD LOT 090424001-04 AND MTS DILUENT 2 LOT MD185

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114743 ↗
• MalfunctionMay 29, 2025False Negative Result; False Negative Result

  CMS (B)(4) WINDCHILL RA610074 A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 AFTER OBSERVING WHAT THEY DESCRIBED AS DISCREPANT NEGATIVE DIRECT ANTIGLOBULIN TESTING (DAT) RESULTS WITH ONE CORD SAMPLE FROM A NEWBORN USING MTS ANTI-IGG CARD LOT 111224001-14 AND MTS DILUENT 2 LOT MD191 IN COMBINATION WITH THEIR ORTHO VISION ID-MTS GEL CARD ANALYZER (B)(6) (SOFTWARE VERSION 5.16.0). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), LABORATORY TECHNOLOGIST. EVENTS DATES: 21 AND 23 APRIL 2025 PATIENT INFORMATION: NEWBORN SAMPLE ID (B)(6) (ENCRYPTED 57-49-83-1F-12-CA-04-C3-50-8E-F0-C6-A2-91-FD-8F-17-F0-EE65-20-7B-31-64-B2-F4-CE-3C-3B-6D-1E-36) EXPECTED TO BE DAT POSITIVE REAGENT: MTS ANTI-IGG CARD (PRODUCT CODE MTS084024; LOT 111224001-14; EXPIRY DATE 13 SEPTEMBER 2025; MANUFACTURE DATE 13 DECEMBER 2024) MTS DILUENT 2 (PRODUCT CODE MTS9230; LOT MD191; EXPIRY DATE 26 SEPTEMBER 2025; MANUFACTURE DATE 26 SEPTEMBER 2024) THE CUSTOMER REPORTED THAT ON (B)(6) 2025 AT 17:54, THEY HAD TESTED SEVERAL TIMES THE ABOVE SAMPLE (B)(6) FROM THIS NEWBORN FOR DAT USING MTS ANTI-IGG CARD LOT 111224001-14 AND MTS DILUENT 2 LOT MD191 IN COMBINATION WITH THEIR ORTHO VISION ID-MTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104246 ↗
• MalfunctionNov 6, 2024False Negative Result; False Negative Result

  CMS (B)(4); WINDCHILL (B)(4) CUSTOMER CONTACTED ORTHO TSC TO REPORT THEY HAD ONE HEEL STICK BLOOD SAMPLE FOR DAT USING MTS ANTI-IGG (RABBIT) GEL CARD LOT 030724001-10 ON THEIR ORTHO VISION ID-MTS ANALYZER (B)(6) AND THAT THEY OBTAINED A FALSE NEGATIVE RESULT. COMPLAINT REPORTER: (B)(6) (MEDICAL TECHNOLOGIST), (B)(6) CUST# (B)(6); (B)(6) DATE OF EVENT: 09OCT2024 REPORTED: (B)(6) 2024 REAGENTS: MTS ANTI-IGG CARD LOT 030724001-10, EXPIRY 03JAN2025, MANUFACTURED 10APR2024 MTS DILUENT 2 LOT MD181, EXPIRY 05DEC2024 ANALYZER: ORTHO VISION ID-MTS, SERIAL (B)(6). NEWBORN INFORMATION: BABY ABORH IS A POS. BABY WAS STILL IN THE NICU AT THE TIME OF AWARENESS BUT DOING WELL AND HAS RECEIVED NO BLOOD PRODUCTS. MOM IS O POS, SO CUSTOMER STATES HEMOLYTIC DISEASE OF THE NEWBORN (HDN) WAS LIKELY DUE TO ABO INCOMPATIBILITY. BILIRUBIN AND HEMATOCRIT ARE CURRENTLY WITHIN NORMAL RANGE. INITIAL HEEL STICK SAMPLE ID - (B)(6) (ENCRYPTED: 4F-1B-AE-7C-8E-F4-3D-07-0F-39-CA-8C-37-63-60-8C-30-A3-59-96-85-8C-2E-87-1E-10-14-33-D7-94-73-92). THE CUSTOMER STATED THAT ONE NEWBORN HEEL STICK SAMPLE WAS TESTED ON THEIR ORTHO VISON ID-MTS ANALYZER IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOT 030724001-10 AND MTS DILUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619396 ↗
• MalfunctionNov 22, 2023False Negative Result; False Negative Result

  (B)(4) WINDCHILL (B)(4) A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 25 OCTOBER 2023 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE RESULTS FOR ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT USING ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD LOT 02243001-14 EXPIRY DATE 17 FEBRUARY 2024 IN MANUAL METHOD. COMPLAINANT/COMPLAINT REPORTER NAME: MRS (B)(6), MEDICAL TECHNOLOGIST. EVENT DATES: 25 OCTOBER 2023. REAGENTS: 0.8% SURGISCREEN LOT VSS502, EXPIRY DATE 14 NOVEMBER2023, MANUFACTURED 12 SEPTEMBER 2023. 0.8% RESOLVE PANEL A LOT VRA442, EXPIRY DATE 31 OCTOBER 2023, MANUFACTURED ON 29 AUGUST 2023. MTS ANTI-IGG CARD LOT 022423001-14, EXPIRY DATE 17 FEBRUARY 2024, MANUFACTURED ON 17 MAY 2023. MTS ANTI-IGG CARD LOT 111521001-15, EXPIRY DATE 21 SEPTEMBER 2022, MANUFACTURED ON 01SEPTEMBER 2021. PATIENT INFORMATION: PATIENT: KNOWN TO HAVE AN ANTI-K(KEL1) ANTIBODY FROM JULY 2018. THE CUSTOMER REPORTED THAT ON 25 OCTOBER 2023, THEY HAD TESTED TWICE A PATIENT SAMPLE FOR ANTIBODY SCREENING IN IAT USING ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD LOT 022423001-14 AND 0.8% SURGISCREEN LOT VSS502 IN MANUAL GEL TECHNIQUE AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191057 ↗
• MalfunctionAug 21, 2023False Negative Result; False Negative Result

  MXP2546159, WINDCHILL RA602979 ON 31 JULY 2023, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE REACTIONS IN MAJOR CROSSMATCH TESTING FOR ONE PROFICIENCY SAMPLE USING MTS ANTI-IGG CARD LOT 120222001-14 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER #(B)(6). DATE OF EVENTS: (B)(6) 2023 AWARENESS DATE: 31 JULY 2023 COMPLAINANT/COMPLAINT REPORTER: (B)(6). LABORATORY SUPERVISOR REPORTED ON 31 JULY 2023 BY THE CUSTOMER TO GTSC. REAGENT: MTS084024 MTS ANTI-IGG CARD SUB LOT 120222001-14, EXPIRY: 04 NOVEMBER 2023 .SOFTWARE VERSION: N/A PROFICIENCY INFORMATION: COLLEGE OF AMERICAN PATHOLOGISTS (CAP) TM AUTOMATED TESTING JAT-B 2023 EXERCISE JAT-11: GROUP O RHD POS, WITH ANTI-S(MNS3) ANTIBODY. JAT-12: GROUP A(ABO1) RHD POS WITH ANTI-C(RH4) ANTIBODY. JAT-13: GROUP O RHD POS DONOR. THE CUSTOMER REPORTED THAT, ON (B)(6) 2023, THEY HAD TESTED SAMPLE JAT-13 FOR MAJOR CROSSMATCH TESTING IN THE INDIRECT AGGLUTINATION TEST (IAT) WITH SAMPLE JAT-11 AND SAMPLE JAT-12 USING MTS ANTI-IGG CARD LOT 120222001-14 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER #(B)(6), AND THAT THEY HAD OBTAINED THE FOLLOWING REACTIONS: JAT-1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17582509 ↗
• MalfunctionJun 19, 2023False Negative Result; False Negative Result

  REPORT 2 OF 2 MXP2529083 RA602303 CUSTOMER CONTACTED ORTHO TSC TO REPORT THEY HAD TESTED TWO CORD BLOOD SAMPLES FOR DAT USING MTS ANTI-IGG (RABBIT) GEL CARD LOT 021023001-01 ON THEIR ORTHO VISION (50003555) AND ORTHO VISION MAX (70002041) AND THAT THEY OBTAINED FALSE NEGATIVE RESULTS. DATE OF EVENT: (B)(6)2023 REPORTED: (B)(6)2023 REAGENTS: MTS ANTI-IGG CARD LOT 021023001-01 MTS DILUENT 2 LOTS MD164 AND MD165 BIASED RESULTS WERE REPORTED TO THE PHYSICIANS. RESULTS WERE QUESTIONED BY CLINICAL STAFF DUE TO HEALTH CONDITIONS OF THE NEWBORNS. HYPERBILIRUBINEMIA OF ONE NEWBORN AND RESPIRATORY DISTRESS OF THE SECOND. PATIENT INFORMATION: NEWBORN A: MOM BLOOD TYPE - O POS BABY BLOOD TYPE - A POS INITIAL CORD SAMPLE ID - (B)(6) (ENCRYPTED ID: 58-1F-B5-3D-8A-28-70-F4-33-FF-7F-A4-01-8E-6E-3C-D4-D5-64-D1-BF-F0-04-95-B5-3F-CD-65-AF-CF-C4-E1) TESTED ON VISON SERIAL # (B)(6) WITH MTS GEL CARD LOT AND MTS DILUENT 2 LOT MD165. A NEGATIVE RESULT WAS OBTAINED AND REPORTED TO THE PHYSICIAN. AN ADDITIONAL HEEL STICK SAMPLE FROM THE NEWBORN WAS COLLECTED AND TESTED ON (B)(6)2023 FOLLOWING DIAGNOSIS OF HYPERBILIRUBINEMIA. PATIENT WAS UNDERGOING TREATMENT FOR HYPERBILIRUBINEMIA AT THE TIME OF REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158325 ↗
• MalfunctionJun 19, 2023False Negative Result; False Negative Result

  REPORT 1 OF 2 MXP2529083 RA602303 CUSTOMER CONTACTED ORTHO TSC TO REPORT THEY HAD TESTED TWO CORD BLOOD SAMPLES FOR DAT USING MTS ANTI-IGG (RABBIT) GEL CARD LOT 021023001-01 ON THEIR ORTHO VISION (50003555) AND ORTHO VISION MAX (70002041) AND THAT THEY OBTAINED FALSE NEGATIVE RESULTS. DATE OF EVENT: (B)(6) 2023 REPORTED: (B)(6) 2023 REAGENTS: MTS ANTI-IGG CARD LOT 021023001-01 MTS DILUENT 2 LOTS MD164 AND MD165 BIASED RESULTS WERE REPORTED TO THE PHYSICIANS. RESULTS WERE QUESTIONED BY CLINICAL STAFF DUE TO HEALTH CONDITIONS OF THE NEWBORNS. HYPERBILIRUBINEMIA OF ONE NEWBORN AND RESPIRATORY DISTRESS OF THE SECOND. PATIENT INFORMATION: NEWBORN A: MOM BLOOD TYPE - O POS BABY BLOOD TYPE - A POS INITIAL CORD SAMPLE ID - (B)(6), (B)(4) TESTED ON VISON SERIAL # (B)(6) WITH MTS GEL CARD LOT AND MTS DILUENT 2 LOT MD165. A NEGATIVE RESULT WAS OBTAINED AND REPORTED TO THE PHYSICIAN. AN ADDITIONAL HEEL STICK SAMPLE FROM THE NEWBORN WAS COLLECTED AND TESTED ON (B)(6) 2023 FOLLOWING DIAGNOSIS OF HYPERBILIRUBINEMIA. PATIENT WAS UNDERGOING TREATMENT FOR HYPERBILIRUBINEMIA AT THE TIME OF REPORTING. NO ADDITIONAL DETAILS WERE PROVIDED WHEN REQUESTED. THE HEEL SAMPLE WAS TESTED IN TUBE METHOD, REAGEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158153 ↗
• MalfunctionMay 22, 2023False Negative Result; False Negative Result

  MXP2521981; RA602093 REPORT 1 OF 2 A CUSTOMER CONTACTED ORTHO REPRESENTATIVE ON (B)(6)2023 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE RESULTS FOR MAJOR CROSSMATCH TESTING IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR TWO PATIENT SAMPLES USING ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD LOT 110222001-11 WITH TWO ORTHO VISION ID-MTS ANALYZERS (50003245 AND 50002594) USED IN A VALIDATION TESTING. SAMPLE 1 WAS A KNOWN O POSITIVE PATIENT WITH AN ANTI-JKA ANTIBODY. -ON (B)(6) 2023, SAMPLE 1 WAS TESTED WITH DONOR 1 (KNOWN TO BE O POSITIVE, JKA ANTIGEN POSITIVE) IN MTS ANTI-IGG CARD LOT 110222001-11 AND FOUND TO BE UNEXPECTANTLY NEGATIVE ON ORTHO VISION ANALYZER 50003245. -AS PART OF TROUBLESHOOTING, ON (B)(6) 2023, SAMPLE 1 WAS TESTED AGAIN WITH DONOR 1 (KNOWN TO BE O POSITIVE, JKA ANTIGEN POSITIVE) IN MTS ANTI-IGG CARD LOT 110222001-11 AND AGAIN FOUND TO BE UNEXPECTANTLY NEGATIVE ON ORTHO VISION ANALYZER 50002594. SAMPLE 2 WAS A KNOWN B POSITIVE PATIENT WITH AN ANTI-JKA ANTIBODY. -ON (B)(6) 2023, SAMPLE 2 WAS TESTED WITH DONOR 2 (KNOWN TO BE B POSITIVE, JKA ANTIGEN POSITIVE) IN MTS ANTI-IGG CARD LOT 110222001-11 AND FOUND TO BE UNEXPECTANTLY NEGATIVE ON ORTHO VISION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974068 ↗
• MalfunctionMay 17, 2023False Negative Result; False Negative Result

  MXP2521981; RA602093 REPORT 2 OF 2 A CUSTOMER CONTACTED ORTHO REPRESENTATIVE ON (B)(6)2023 AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE RESULTS FOR MAJOR CROSSMATCH TESTING IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR TWO PATIENT SAMPLES USING ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD LOT 110222001-11 WITH TWO ORTHO VISION ID-MTS ANALYZERS (50003245 AND 50002594) USED IN A VALIDATION TESTING. SAMPLE 1 WAS A KNOWN O POSITIVE PATIENT WITH AN ANTI-JKA ANTIBODY. ON (B)(6) 2023, SAMPLE 1 WAS TESTED WITH DONOR 1 (KNOWN TO BE O POSITIVE, JKA ANTIGEN POSITIVE) IN MTS ANTI-IGG CARD LOT 110222001-11 AND FOUND TO BE UNEXPECTANTLY NEGATIVE ON ORTHO VISION ANALYZER 50003245. AS PART OF TROUBLESHOOTING, ON (B)(6) 2023, SAMPLE 1 WAS TESTED AGAIN WITH DONOR 1 (KNOWN TO BE O POSITIVE, JKA ANTIGEN POSITIVE) IN MTS ANTI-IGG CARD LOT 110222001-11 AND AGAIN FOUND TO BE UNEXPECTANTLY NEGATIVE ON ORTHO VISION ANALYZER 50002594. SAMPLE 2 WAS A KNOWN B POSITIVE PATIENT WITH AN ANTI-JKA ANTIBODY. ON (B)(6) 2023, 1 SAMPLE 2 WAS TESTED WITH DONOR 2 (KNOWN TO BE B POSITIVE, JKA ANTIGEN POSITIVE) IN MTS ANTI-IGG CARD LOT 110222001-11 AND FOUND TO BE UNEXPECTANTLY NEGATIVE ON ORTHO VISION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948156 ↗
• MalfunctionJan 18, 2023False Negative Result; False Negative Result

  MXP2491367 WINDCHILL RA600572 (REPORT 2 OF 2) DISCORDANT NEGATIVE ANTIBODY SCREENING RESULTS FOR TWO PATIENTS HAVING AN ANTI-E(RH3) ANTIBODY. THE ASSIGNABLE CAUSE IS SAMPLE RELATED, THE PATIENTS ANTI-E(RH3) ANTIBODY BEING WEAK AND/OR AT THE DETECTION LIMIT OF THE TECHNIQUE AND REAGENTS USED AND/OR ASSOCIATED TO THE VARIABILITY OF THE E(RH3) ANTIGEN PRESENT ON THE REAGENT RED BLOOD CELLS. NO REAGENT FAILURE IS IDENTIFIED. NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE PATIENTS WERE NOT HARMED. PROBLEM STATEMENT AND DESCRIPTION: CUSTOMER REPORTING FALSE NEGATIVE ANTIBODY SCREENS ON TWO PATIENTS USING IGG GEL CARD LOT#: 062322001-11 WITH 0.8% SURGISCREEN VSS423 BY MANUAL GEL RELEVANT INFORMATION: - ISSUE STARTED ON (B)(6) 2022 - MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED:SC2 - REACTION GRADE OBTAINED: NEGATIVE - CUSTOMER WAS EXPECTING: POSITIVE - INCUBATION TIME (FOR MANUAL TEST ONLY):15MINS - TEST REPEATED: YES - METHOD/RESULT OBTAINED BY REPEATING: REPEATED MANUAL GEL, STILL NEGATIVE - NUMBER OF SAMPLES AFFECTED? 2 PATIENTS - WAS QC AFFECTED? NO - WAS ANY EXPIRED PRODUCT USED? NO - WHEN WAS THE LAST SUCCESSFUL QC RUN? ON (B)(6) 2022 USING ORTHO CONFIDENCE CNF291, ALL CELLS 3+

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16199225 ↗
• MalfunctionJan 18, 2023False Negative Result; False Negative Result

  MXP2494934 WINDCHILL RA600707 DISCORDANT NEGATIVE ANTIBODY SCREENING RESULTS FOR TWO PATIENTS HAVING AN ANTI-E(RH3) ANTIBODY. THE ASSIGNABLE CAUSE IS SAMPLE RELATED, THE PATIENTS ANTI-E(RH3) ANTIBODY BEING WEAK AND/OR AT THE DETECTION LIMIT OF THE TECHNIQUE AND REAGENTS USED AND/OR ASSOCIATED TO THE VARIABILITY OF THE E(RH3) ANTIGEN PRESENT ON THE REAGENT RED BLOOD CELLS. NO REAGENT FAILURE IS IDENTIFIED. NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE PATIENTS WERE NOT HARMED. PROBLEM STATEMENT AND DESCRIPTION: AS A PART OF TROUBLESHOOTING MXP2491367 CUSTOMER REPORTS FALSE NEGATIVE ANTIBODY SCREENS ON PATIENT WITH PREVIOUSLY ID ANTI E USING IGG GEL CARD LOT#: 092322001-02 WITH 0.8% SURGISCREEN VSS423 BY MANUAL GEL RELEVANT INFORMATION: - ISSUE STARTED ON (B)(6) 2022 - MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: SC2 - REACTION GRADE OBTAINED: NEGATIVE - CUSTOMER WAS EXPECTING:POSITIVE - INCUBATION TIME (FOR MANUAL TEST ONLY): 15MINS - TEST REPEATED: NO - NUMBER OF SAMPLES AFFECTED? 2 PATIENTS - WAS QC AFFECTED?NO - WAS ANY EXPIRED PRODUCT USED? NO - WHEN WAS THE LAST SUCCESSFUL QC RUN? 12/24/22 USING ORTHO CONFIDENCE CNF291, ALL CELLS 3+ PRODUCT HANDLING PROTOCOL: - CASSETTE/G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196286 ↗
• MalfunctionJan 18, 2023False Negative Result; False Negative Result

  MXP2491367 WINDCHILL RA600572 DISCORDANT NEGATIVE ANTIBODY SCREENING RESULTS FOR TWO PATIENTS HAVING AN ANTI-E(RH3) ANTIBODY. THE ASSIGNABLE CAUSE IS SAMPLE RELATED, THE PATIENTS ANTI-E(RH3) ANTIBODY BEING WEAK AND/OR AT THE DETECTION LIMIT OF THE TECHNIQUE AND REAGENTS USED AND/OR ASSOCIATED TO THE VARIABILITY OF THE E(RH3) ANTIGEN PRESENT ON THE REAGENT RED BLOOD CELLS. NO REAGENT FAILURE IS IDENTIFIED. NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE PATIENTS WERE NOT HARMED. PROBLEM STATEMENT AND DESCRIPTION: CUSTOMER REPORTING FALSE NEGATIVE ANTIBODY SCREENS ON TWO PATIENTS USING IGG GEL CARD LOT#: 062322001-11 WITH 0.8% SURGISCREEN VSS423 BY MANUAL GEL RELEVANT INFORMATION: - ISSUE STARTED ON (B)(6) 2022 - MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED:SC2 - REACTION GRADE OBTAINED: NEGATIVE - CUSTOMER WAS EXPECTING: POSITIVE - INCUBATION TIME (FOR MANUAL TEST ONLY): 15MINS - TEST REPEATED: YES - METHOD/RESULT OBTAINED BY REPEATING: REPEATED MANUAL GEL, STILL NEGATIVE - NUMBER OF SAMPLES AFFECTED? 2 PATIENTS - WAS QC AFFECTED? NO - WAS ANY EXPIRED PRODUCT USED? NO - WHEN WAS THE LAST SUCCESSFUL QC RUN? 12/24/2022 USING ORTHO CONFIDENCE CNF291, ALL CELLS 3+ PRODUCT HANDLING PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196184 ↗
• InjuryJan 9, 2023False Negative Result; False Negative Result

  (B)(4). ON (B)(6) 2022, A CUSTOMER COMPLAINED TO ORTHO CARE ABOUT WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE ANTIBODY SCREENING RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT¿S SAMPLE USING MTS ANTI-IGG CARD (LOT NUMBER NOT PROVIDED) IN MANUAL GEL METHOD AND THE PATIENT HAD A TRANSFUSION REACTION. PATIENT¿S INFORMATION: NO PRIOR ANTIBODY HISTORY THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THEY HAD TESTED A SAMPLE FROM THIS PATIENT FOR ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) USING MTS ANTI-IGG CARD IN MANUAL GEL METHOD AND THAT THEY OBTAINED A NEGATIVE ANTIBODY SCREENING RESULT. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THE PATIENT HAD A TRANSFUSION REACTION UPON TRANSFUSION. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE PATIENT HAD COLD AGGLUTININS AND POSSIBLY ALSO ROULEAUX FORMATION. THE CUSTOMER REPORTED THAT IT WAS CORRECTED BY SALINE REPLACEMENT. NO FURTHER DETAIL WAS PROVIDED. INVESTIGATION: THE CUSTOMER REPORTED THAT THEY HAD PROCESSED QC SAMPLES TO VALIDATE GEL TECHNIQUE ON THE DAY OF THE EVENT AND THAT THE RESULTS WERE AS EXPECTED. THE CONFIRMATION WAS NOT PROVIDE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16121954 ↗