VITROS 6844461Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 10758750031610), received between Nov 16, 2022 and Sep 10, 2026 — classified as 1 injury, 91 malfunctions.

The most frequently reported specific device problem is “High Test Results” (58 reports).

6 FDA recall records name this device's identifier, 6 still open.

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.

Recalls naming this device

1. Jan 26, 2024Open, Classified

   A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

   Z-1233-2024 · Root cause: Software Design Change · FDA record ↗

2. Jan 26, 2024Open, Classified

   A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

   Z-1228-2024 · Root cause: Software Design Change · FDA record ↗

3. Jan 22, 2024Open, Classified

   Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

   Z-1222-2024 · Root cause: Component change control · FDA record ↗

4. Oct 10, 2023Open, Classified

   During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

   Z-0547-2024 · Root cause: Under Investigation by firm · FDA record ↗

5. Mar 10, 2023Open, Classified

   MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

   Z-1555-2023 · Root cause: Under Investigation by firm · FDA record ↗

6. Jul 19, 2022Open, Classified

   Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

   Z-1676-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716375 ↗
• MalfunctionJun 18, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED AMMONIA (AMON) RESULT OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1023-0271-0638 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS CONTROL LOT AA2709 L2 RESULT OF 121.1 UMOL/L VS THE EXPECTED RESULT OF 160.6 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS AMON RESULT WAS OBTAINED WHEN PROCESSING A CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548159 ↗
• MalfunctionJun 9, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED AMMONIA (AMON) RESULT OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1023-0271-0995 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS CONTROL LOT AA2709 L2 RESULT OF 179.0 UMOL/L VS THE EXPECTED RESULT OF 146.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS AMON RESULT WAS OBTAINED WHEN PROCESSING A CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 614813.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445893 ↗
• MalfunctionJun 5, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) I (LOT E2828) PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4208-1180-9097 ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. VITROS XT 7600 INTEGRATED SYSTEM: S/N 76001288 (J1): PERFORMANCE VERIFIER I (LOT E2828) OBSERVED RESULTS OF >250.0, >250.0, >250.0, >250.0, >250.0, AND >250.0 MMOL/L VS THE EXPECTED RESULT OF 125.7 MMOL/L. VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) (J2): PATIENT 2 RESULT OF 189.2 MMOL/L VS AN EXPECTED (REPEAT) RESULT FROM J1 OF 112.3 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. ONE PATIENT SAMPLE WAS DETERMINED TO BE AFFECTED ((B)(6) 2026), HOWEVER, THIS RESULT WAS NOT REPORTED AND THE CUSTOMER CONFIRMED THAT THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414528 ↗
• MalfunctionMay 26, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT QUALITY CONTROL RESULTS SHIFTED LOW ON TWO LEVELS OF NON-VITROS EUROBIO QUALITY CONTROL (QC) FLUID USING MULTIPLE VITROS MICROWELL ASSAYS. ALTHOUGH MULTIPLE MICROWELL ASSAYS WERE AFFECTED, ONLY RESULTS OBTAINED FROM THE VITROS NBNP2, TSH3, AND HSTNI ASSAYS MET POTENTIAL HEALTH AND SAFETY (PHS) CRITERIA. VITROS NBNP2 REAGENT (LOT 2290): NON-VITROS EUROBIO (LOT 2309898) LEVEL 1 RESULT OF 20.0 PG/ML VS. THE EXPECTED RESULT OF 95.0 PG/ML NON-VITROS EUROBIO (LOT 2309899) LEVEL 1 RESULT OF 25.3 PG/ML VS. THE EXPECTED RESULT OF 1,635.0 PG/ML VITROS TSH3 REAGENT (LOT 1100): NON-VITROS EUROBIO (LOT 2309898) LEVEL 1 RESULT OF 1.67 MIU/L VS. THE EXPECTED RESULT OF 2.62 MIU/L NON-VITROS EUROBIO (LOT 2309899) LEVEL 1 RESULT OF 2.57 MIU/L VS. THE EXPECTED RESULT OF 10.05 MIU/L VITROS HSTNI REAGENT (LOT 1580): NON-VITROS EUROBIO (LOT 2309898) LEVEL 1 RESULT OF 8.75 NG/L VS. THE EXPECTED RESULT OF 77.40 NG/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. PATIENT SAMPLES WERE NOT AFFECTED AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280738 ↗
• MalfunctionMay 20, 2026High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED CREATININE KINASE MB (CKMB) RESULT WAS OBTAINED FROM ONE LEVEL OF MAS CARDIOIMMUNE XL QUALITY CONTROL (QC) FLUID LOT: CXL2704 USING VITROS CKMB2, LOT: 0201. IN ADDITION, HIGHER AND LOWER THAN EXPECTED NT-PROBNP II (NBNP2) RESULTS WERE OBTAINED FROM VITROS NBNP2 LOT: 0690 WHEN PROCESSING TWO LEVELS OF MAS QC FLUIDS, A SINGLE PATIENT SAMPLE, AND TWO LEVELS OF VITROS NBNP2 QC FLUIDS ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS CKMB2 MAS LEVEL 2 RESULT OF 2.59 NG/ML VERSUS THE EXPECTED RESULT OF 3.46 NG/ML VITROS NBNP2 MAS LEVEL 1 RESULT OF 250.45 PG/ML VERSUS THE EXPECTED RESULT OF 345.0 PG/ML VITROS NBNP2 MAS LEVEL 2 RESULTS OF 1143.04, 1253.45, 1265.95, 1103.69 PG/ML VERSUS THE EXPECTED RESULT OF 1753.0 PG/ML VITROS NBNP2 PATIENT RESULT OF 836.78 PG/ML VERSUS THE EXPECTED RESULT OF 1153.46 PG/ML VITROS NBNP2 LEVEL 1 VITROS NBNP2 QC RESULT OF 163.26 PG/ML VERSUS THE EXPECTED RESULT OF 98.0 PG/ML VITROS NBNP2 LEVEL 2 VITROS NBNP2 QC RESULT OF 1507.45, 652.57, 607.15, 721.43, 633.71 PG/ML VERSUS THE EXPECTED RESULT OF 998.0 PG/ML BIASED RESULTS OF THE MAGNITUDE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233230 ↗
• MalfunctionMay 14, 2026High Test Results

  AN ORTHO FIELD APPLICATION SPECIALIST (FAS), ON BEHALF OF A CUSTOMER, CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM RESULTS OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4201-1173-6016 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LOT 89760 L2 RESULTS OF 156.3, 151.3, 154.8, 154.9, 158.0, 154.2, 155.4 AND 163.0 MMOL/L VS AN EXPECTED RESULT OF 127.8 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE ORTHO TSC INQUIRED IF ANY PATIENT SAMPLE RESULTS HAVE BEEN AFFECTED OR QUESTIONED, HOWEVER, THE CUSTOMER DID NOT PROVIDE ANY INFORMATION. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171468 ↗
• MalfunctionApr 7, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT - PROBNP II (NBNP2) RESULTS OBTAINED FROM VITROS NBNP2 LOT 0660 WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS LT QUALITY CONTROL (QC) FLUID LOT 67710 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD L2 VITROS NBNP RESULTS OF 124.0 AND 146.1 PG/ML VS EXPECTED RESULT OF 195.1 PG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS NBNP2 RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS QC FLUID. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802146 ↗
• MalfunctionApr 7, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE, HIGHER-THAN-EXPECTED TROPONIN ES RESULTS OBTAINED FROM FOUR DIFFERENT PATIENT SAMPLES WHEN USING VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES (TROPI ES) REAGENT PACK, LOT: 6390 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT RESULTS OBTAINED FROM THE SAME PATIENT SAMPLES ON A SECOND VITROS XT 7600 INTEGRATED SYSTEM. ADDITIONALLY, HIGHER THAN EXPECTED VITROS TROPI ES LOT: 6390 RESULTS WERE OBTAINED DURING A PRECISION TEST USING SPECIALTY DILUENT FLUID (KNOWN TROPONIN FREE SAMPLE). VITROS XT 7600 INTEGRATED SYSTEM: S/N: (B)(6) (J1) PATIENT 1, VITROS TROPI ES RESULT OF 0.069 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 2, VITROS TROPI ES RESULTS OF 0.087, 0.072, AND 0.075 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 3, VITROS TROPI ES RESULTS OF 0.078 AND 0.057 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 4, VITROS TROPI ES RESULT OF 0.073 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML VITROS TROPI ES PRECISION RESULTS OF 0.061, 0.059 AND 0.067 NG/ML VERSUS THE EXPECTED RESULT O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799596 ↗
• MalfunctionMar 24, 2026High Test Results; Non Reproducible Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS NA+ RESULTS OBTAINED FROM A SINGLE NON-VITROS BIORAD MULTIQUAL LIQUID ASSAYED CONTROL, LOT 46040 FLUID USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDE LOT 4216-1188-1616 ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD L1 VITROS NA+ RESULTS OF >250 AND 136.0 MMOL/L VS. THE EXPECTED BASELINE MEAN RESULT OF 114.3 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS, HOWEVER, THE CUSTOMER STATED THAT PATIENT SAMPLE RESULTS WERE ALSO AFFECTED. HOWEVER, NO SPECIFIC DATA CONCERNING PATIENT SAMPLE RESULTS WAS PROVIDED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674590 ↗
• MalfunctionMar 23, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, HIGHER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED WHEN SAMPLES FROM TWO DIFFERENT PATIENTS WERE TESTED USING VITROS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 1492 ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED DISCORDANT UPON REPEAT TESTING OF THE SAME PATIENT SAMPLES. VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) (J1) PATIENT 1, SAMPLE 1, VITROS HSTNI RESULT 37.68 NG/L (ABOVE CUTOFF) VS. EXPECTED HSTNI RESULT OF 4.29 NG/L (BELOW CUTOFF) VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6) (J2) PATIENT 2, SAMPLE 1, VITROS HSTNI RESULT 30.37 NG/L (ABOVE CUTOFF) VS. EXPECTED HSTNI RESULT OF 8.01 NG/L (BELOW CUTOFF) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, HIGHER THAN EXPECTED VITROS HSTNI RESULTS WERE REPORTED BY THE LABORATORY; HOWEVER, THE PHYSICIAN LATER QUESTIONED THE RESULTS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM RELATED TO THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669923 ↗
• MalfunctionMar 23, 2026High Test Results

  THE INVESTIGATION DETERMINED THAT DISCORDANT, HIGHER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED WHEN SAMPLES FROM TWO DIFFERENT PATIENTS WERE TESTED USING VITROS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 1492 ON TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED DISCORDANT UPON REPEAT TESTING OF THE SAME PATIENT SAMPLES. VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6), (J1) PATIENT 1, SAMPLE 1, VITROS HSTNI RESULT 37.68 NG/L (ABOVE CUTOFF) VS. EXPECTED HSTNI RESULT OF 4.29 NG/L (BELOW CUTOFF) VITROS XT 7600 INTEGRATED SYSTEM: S/N (B)(6), (J2) PATIENT 2, SAMPLE 1, VITROS HSTNI RESULT 30.37 NG/L (ABOVE CUTOFF) VS. EXPECTED HSTNI RESULT OF 8.01 NG/L (BELOW CUTOFF) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, HIGHER THAN EXPECTED VITROS HSTNI RESULTS WERE REPORTED BY THE LABORATORY; HOWEVER, THE PHYSICIAN LATER QUESTIONED THE RESULTS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM RELATED TO THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665392 ↗
• MalfunctionMar 12, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED HBA1C RESULTS OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROLS AS WELL AS SAMPLES FROM TWO DIFFERENT PATIENTS PROCESSED USING VITROS CHEMISTRY PRODUCTS HEMOGLOBIN A1C (HBA1C) REAGENT LOT 1539-47-3424 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LOT 89250 L1 RESULTS OF 7.36, 7.42, 7.32, 7.35 AND 7.23 %A1C VS AN EXPECTED RESULT OF 5.33 %A1C BIORAD LOT 89250 L2 RESULTS OF 13.15, 13.13, 13.36, 13.27 AND 13.08 %A1C VS AN EXPECTED RESULT OF 8.26 %A1C PATIENT 1 RESULT OF 7.8 %A1C VS AN EXPECTED RESULT OF 5.5 %A1C PATIENT 2 RESULT OF 8.6 %A1C VS AN EXPECTED RESULT OF 6.0 %A1C BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM CONTROL FLUIDS AND WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT PROCESS PATIENT SAMPLES AFTER THE HIGHER THAN EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED OTHER THAN FOR TROUBLESHOOTING PURPOSES AND THE RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE HAVE BEEN NO ALLEGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586609 ↗
• MalfunctionMar 10, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IGA QUALITY CONTROL RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LIQUICHEK IMMUNOLOGY CONTROLS, LOT 85780, ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 1 VITROS IGA RESULTS OF 92.6, 90.3 AND 90.0 MG/DL VS. THE EXPECTED RESULT OF 132.3 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560223 ↗
• MalfunctionMar 6, 2026High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER AND LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1019-0266-5792 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS CONTROL LOT AA2604 L2 VITROS AMON RESULTS OF 115.8, 108.7, 119.0, 82.1, 108.2, 115.4, 104.2, 113.3, 117.0, 110.7, 111.0, 112.2, 112.4, 90.9, 181.6, 180.2, 180.1, 180.2, 182.4, 179.6, 182.5, 180.8, 182.3, 180.6, 212.3, 195.8, 191.7, 182.8, 181.8, 186.3, 182.7, 179.6, 180.7, 181.9, 179.3, 180.4 AND 182.2 UMOL/L VERSUS AN EXPECTED RESULT OF 149.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER AND LOWER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING A CONTROL FLUID. THE CUSTOMER STATED THAT NO PATIENT SAMPLE RESULTS HAVE BEEN QUESTIONED BY PHYSICIANS. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533569 ↗
• MalfunctionFeb 18, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE CONTROL, LOT: OCR2608, TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS NA+ RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE EXPECTED ESTABLISHED TARGET FOR THE MAS CONTROLS. VITROS NA+ SLIDE LOT: 4287-1167-4622 MAS LEVEL 1 NA+ RESULTS OF 146.2, 146.9 AND 136.9 MMOL/L VS. THE EXPECTED RESULT OF 120.33 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE VITROS NA+ RESULTS THAT MET POTENTIAL HEALTH AND SAFETY CRITERIA WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381056 ↗
• MalfunctionFeb 5, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NBNP2) RESULTS WERE OBTAINED FROM VITROS NBNP2 LOT 0590 WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS LT QUALITY CONTROL (QC) FLUID LOT 1003130 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 VITROS NBNP RESULTS OF 143.2, 143.3 PG/ML VS EXPECTED RESULT OF 202.6 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS NBNP2 RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS QC FLUID. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 613299.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272165 ↗
• MalfunctionFeb 5, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS LT QUALITY CONTROL (QC) FLUID LOT 1003110 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 RESULTS OF 10.93, 11.07, 11.30 AND 12.87 PMOL/L VS EXPECTED RESULT OF 17.3 PMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS NTBNP II RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS QC FLUID. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272105 ↗
• MalfunctionDec 18, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT HIGHER THAN EXPECTED VITROS ALCOHOL (ALC) RESULTS WERE OBTAINED ON TWO SAMPLES FROM THE SAME PATIENT AND A QUALITY CONTROL FLUID USING A VITROS CREATININE KINASE (CK) SLIDE CARTRIDGE THAT WAS MISIDENTIFIED AS A VITROS ALC SLIDE CARTRIDGE ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE 1: ALC = >300 MG/DL, >600 MG/DL WITH 2X DILUTION PATIENT SAMPLE 2: ALC = >300 MG/DL, >600 MG/DL WITH 2X DILUTION BIORAD LEVEL 1: ALC = >300 MG/DL VERSUS BASELINE MEAN 48.2 MG/DL BIORAD LEVEL 2: ALC = >300 MG/DL VERSUS BASELINE MEAN 145.2 MG/DL ASSAY RESULTS OBTAINED FROM A SLIDE CARTRIDGE (CK) OTHER THAN THE INTENDED SLIDE CARTRIDGE (ALC) MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE HIGHER-THAN-EXPECTED VITROS ALC PATIENT RESULTS WERE REPORTED FROM THE LABORATORY; HOWEVER, A CORRECTED REPORT WAS LATER ISSUED WITH A REPEAT VITROS ALC RESULT OF <10 MG/DL. THE PATIENT WAS ADMITTED BASED ON THE HIGHER-THAN-EXPECTED RESULTS; HOWEVER. NO TREATMENT WAS STOPPED, STARTED OR ALTERED DURING THIS TIMEFRAME AND THE PATIENT WAS RELEASED UPON THE REPEAT TESTING. THERE WAS NO ALLEGATION OF PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839425 ↗
• MalfunctionNov 20, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM VITROS LIQUID PERFORMANCE VERIFIERS (LPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1020-0268-5858 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS LPV I LOT L2778 RESULT OF 103.0 UMOL/L VERSUS AN EXPECTED RESULT OF 46.0 UMOL/L VITROS LPV II LOT M2779 RESULTS OF 138.7 AND 154.1 UMOL/L VERSUS AN EXPECTED RESULT OF 200.0 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER AND HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING CONTROL FLUIDS AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER DID NOT INDICATE THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605865 ↗
• MalfunctionNov 19, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM A NON-VITROS MAS ALCOHOL/AMMONIA CONTROL PROCESSED USING VITROS AMON SLIDE LOT 1020-0268-5827 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS LEVEL 2 LOT AA2604 VITROS AMON RESULTS OF 113.85, 110.8, AND 113.5 UMOL/L VERSUS THE EXPECTED RESULT OF 142.75 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING A CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT PATIENT RESULTS WERE NOT IMPACTED BY THIS ISSUE. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597465 ↗
• MalfunctionOct 20, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER AND LOWER THAN EXPECTED PHENYTOIN (PHYT) RESULTS WERE OBTAINED FROM NON-VITROS BIORAD QUALITY CONTROLS PROCESSED USING VITROS CHEMISTRY PRODUCTS PHYT SLIDES LOT 2627-0193-5577 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LOT 40450 LEVEL 2 RESULT OF 8.35 UG/ML VS AN EXPECTED RESULT OF 12.59 UG/ML BIORAD LOT 40450 LEVEL 3 RESULTS OF 15.94, 15.32, 17.45, 26.87, 16.34, 16.25 AND 31.58 UG/ML VS AN EXPECTED RESULT OF 22.33 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT CONTROL FLUIDS AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER DID NOT INDICATE THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 612208.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336370 ↗
• MalfunctionOct 16, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID AND A SINGLE LEVEL OF NON-VITROS MAS QC FLUID PROCESSED USING TWO DIFFERENT LOTS OF VITROS CHEMISTRY PRODUCTS AMON SLIDES ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS AMON SLIDE LOT 1019-0266-5909: BIORAD LOT 54470 (LEVEL 2) VITROS AMON RESULTS OF 106.4, 119.1, AND 129.2 UMOL/L VERSUS THE EXPECTED RESULT OF 88.0 UMOL/L VITROS AMON SLIDE LOT 1020-0267-8605: MAS LOT AA2604 (LEVEL 2) VITROS AMON RESULT OF 109.5 UMOL/L VERSUS THE EXPECTED RESULT OF 143.5 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER AND HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING NON-PATIENT CONTROL FLUIDS. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER CLAIMED THAT PATIENT RESULTS WERE NOT IMPACTED BY THIS ISSUE. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316314 ↗
• MalfunctionOct 16, 2025Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER (LPV) PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT: 1020-0267-3612 ON A VITROS XT 7600 INTEGRATED SYSTEM. LPV II LOT: M2779 VITROS AMON RESULTS OF 144.5 AND 118.3 UMOL/L VERSUS THE EXPECTED RESULT OF 191.12 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING A CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER CLAIMED THAT PATIENT RESULTS WERE NOT IMPACTED BY THIS ISSUE. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23315997 ↗
• MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT MULTIPLE PATIENT AND QUALITY CONTROL SAMPLES WERE TESTED WITH A VITROS CA SLIDE CARTRIDGE THAT WAS MIS-IDENTIFIED AS A VITROS ALTV SLIDE CARTRIDGE ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PV I, LOT E2828 RESULTS OF 45.7, 45.2 AND 44.9 U/L VS. THE RANGE OF MEANS MIDPOINT VALUE OF 121.4 U/L VITROS PV II, LOT D2338 RESULTS OF 280.3, 280.7 AND 277.7 U/L VS. THE RANGE OF MEANS MIDPOINT VALUE OF 138.7 U/L PATIENT SAMPLE RESULTS WERE NOT LISTED AS THE CUSTOMER DID NOT PROVIDE THE EXPECTED RESULTS. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE ORTHO TSC MADE MULTIPLE FOLLOW UP ATTEMPTS WITH THE CUSTOMER TO DETERMINE IF THE AFFECTED PATIENT SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, AND IF THE SAMPLES WERE RETESTED AND IF CORRECT REPORTS WERE ISSUED. THE CUSTOMER HAS NOT YET PROVIDED THE REQUESTED INFORMATION AFTER MULTIPLE ATTEMPTS BY THE ORTHO TSC TO OBTAIN THE INFORMATION. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22969383 ↗