VITROS 1662659Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10758750009503), received between Dec 15, 2022 and Sep 24, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 16, 2019Terminated

   Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2

   Z-1226-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Use of Device Problem

  A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report that the operator sustained a thumb laceration during separate events involving the removal of metal seals from various VITROS Calibrator bottles. The operator did not seek medical attention or treatment for any of the injuries. No long-term serious injury was sustained. The operator did not seek medical treatment for the lacerations. The injury did not require any medical attention. There was no allegation of a serious or long-term permanent injury. 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 50882098 ↗
• MalfunctionMay 20, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS K+ RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF A NON-VITROS THERMOFISHER MAS CONTROL (LOT OCR2608) USING VITROS CHEMISTRY PRODUCTS POTASSIUM (K+) SLIDE LOT 4102-0842-1653 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS OCR2608 L3 RESULTS OF 3.80, 4.74, 4.82, 4.82, 4.82, 3.82, AND 4.76 MMOL/L VS. THE EXPECTED RESULT OF 6.91 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 LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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 25232313 ↗
• MalfunctionMay 13, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) SLIDE LOT 4213-1185-0237 AND VITROS POTASSIUM (K+) SLIDE LOT 4102-1197-9201 RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL ASSAYED LOT 46030 CONTROLS TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 1 NA+ RESULTS OF 193.5, 192.8, 191.1, 195.3 AND 194.9 MMOL/L VS. THE EXPECTED RESULT OF 114.99 MMOL/L BIORAD LEVEL 1 K+ RESULTS OF 4.48, 4.49, 4.48, 4.54 AND 4.55 MMOL/L VS. THE EXPECTED RESULT OF 2.58 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 RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, UNKNOWN SAMPLES THAT MAY HAVE BEEN PATIENT SAMPLES WERE PROCESSED IN THE TIMEFRAME OF THE EVENT. THERE WAS 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 25162988 ↗
• MalfunctionFeb 27, 2026High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL USING VITROS CHEMISTRY PRODUCTS: POTASSIUM (K+) SLIDES LOT 4102-0965-8156 AND VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4208-1180-8532 PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS NA+ MAS LOT OCR2704 LEVEL 1 RESULTS OF 187.1 AND 187.6 MMOL/L VS AN EXPECTED RESULT OF 118.0 MMOL/L VITROS K+ MAS LOT OCR2704 LEVEL 1 RESULT OF 4.29 MMOL/L VS AN EXPECTED RESULT OF 2.65 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 RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED AFTER THE UNACCEPTABLE QC RESULTS WERE OBTAINED. 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 24470101 ↗
• MalfunctionFeb 20, 2026Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF A NON-VITROS BIORAD CONTROL (LOT 46020) USING VITROS NA+ SLIDE LOT 4284-1177-7102 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD 46020 LEVEL 3 RESULTS OF 143.0 AND 144.0 MMOL/L VS. THE EXPECTED RESULT OF 164.6 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 LOWER-THAN-EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE. 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 24403437 ↗
• MalfunctionFeb 13, 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 NON-VITROS BIORAD LEVEL 1 QUALITY CONTROL FLUID, LOT 93030, USING VITROS NA+ SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1 NA+ RESULTS OF 137.1 AND 140.1MMOL/L VS. THE EXPECTED RESULT OF 123.1 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 AFFECTED SAMPLES WERE NON-PATIENT QUALITY CONTROL SAMPLES. 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. 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 24331936 ↗
• MalfunctionFeb 13, 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 NON-VITROS BIORAD LEVEL 1 QUALITY CONTROL FLUID, LOT: 93030, USING VITROS NA+ SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1 NA+ RESULTS OF 137.1 AND 140.1MMOL/L VS. THE EXPECTED RESULT OF 123.1 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 AFFECTED SAMPLES WERE NON-PATIENT QUALITY CONTROL SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331933 ↗
• MalfunctionNov 13, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4282-1162-3115 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PV I LOT E2828 RESULTS OF 141.0 AND 136.9 MMOL/L VS THE EXPECTED RESULT OF 126.2 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER-THAN-EXPECTED RESULTS WERE FROM A NON-PATIENT CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THERE WAS 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 23547040 ↗
• MalfunctionOct 22, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) AND VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS QUALITY CONTROL LOT OCR2608 USING VITROS NA+ SLIDE LOT 4267-1147-8156 AND VITROS K+ SLIDE LOT 4102-1161-8103 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS NA+ MAS LEVEL 1 LOT OCR2608 RESULT OF 182.9 MMOL/L VERSUS THE EXPECTED RESULT OF 121.1 MMOL/L (BASELINE MEAN) VITROS K+ MAS LEVEL 1 LOT OCR2608 RESULT OF 4.09 MMOL/L VERSUS THE EXPECTED RESULT OF 2.65 MMOL/L (BASELINE MEAN) 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 MAS QUALITY CONTROL RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES; HOWEVER, THE INVESTIGATION COULD NOT RULE OUT IF PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357677 ↗
• MalfunctionJul 30, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS NA+ AND VITROS K+ RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF A NON-VITROS THERMOFISHER MAS CONTROL (LOT: OCR2608) USING VITROS SODIUM (NA+) SLIDE LOT: 4272-1152-0701 AND VITROS POTASSIUM (K+) SLIDE LOT: 4102-0918-6250 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS NA+ SLIDE LOT: 4272-1152-0701 MAS OCR2608 L1 RESULTS OF 205.4, 203.3, 203.7, 203.0, 204.6, 205.2, AND 203.9 MMOL/L VS. THE EXPECTED RESULT OF 121.1 MMOL/L VITROS K+ SLIDE LOT: 4102-0918-6250 MAS OCR2608 L1 RESULTS OF 4.56, 4.58, 4.54, 4.53, 4.51, 4.55, 4.56, 4.6, 4.57, AND 4.51 MMOL/L VS. THE EXPECTED RESULT OF 2.65 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 RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE; HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665150 ↗
• MalfunctionJul 23, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS NA+ AND VITROS K+ RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF A NON-VITROS THERMOFISHER MAS CONTROL (LOT OCR2608) USING VITROS SODIUM (NA+) SLIDE LOT 4272-1152-0701 AND VITROS POTASSIUM (K+) SLIDE LOT 4102-0918-6250 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS NA+ SLIDE LOT 4272-1152-0701 MAS OCR2608 L1 RESULTS OF 205.5 AND 205.3 MMOL/L VS. THE EXPECTED RESULT OF 121.1 MMOL/L VITROS K+ SLIDE LOT 4102-0918-6250 MAS OCR2608 L1 RESULTS OF 4.58 AND 4.54 MMOL/L VS. THE EXPECTED RESULT OF 2.65 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 RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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 REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575367 ↗
• MalfunctionApr 21, 2025High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) USING VITROS CHEMISTRY PRODUCTS K+ SLIDES LOT 4102-1153-4901 AND VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4261-1141-5716 PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. TWO SEPARATE EVENTS OCCURRED: EVENT 1: VITROS NA+ VITROS PV I LOT B2245 RESULT OF 138.3 MMOL/L VS AN EXPECTED RESULT OF 116.4 MMOL/L EVENT 2: VITROS NA+ VITROS PV I LOT B2245 RESULTS OF 138.3, 138.4, 139.2, 137.7, 137.4, 138.8, 138.0, 137.3 AND 138.4 MMOL/L VS AN EXPECTED RESULT OF 116.4 MMOL/L VITROS K+ VITROS PV I LOT B2245 RESULTS OF 3.55, 3.59, 3.55, 3.52, 3.54, 3.55, 3.51, 3.53 AND 3.52 MMOL/L VS AN EXPECTED RESULT OF 2.89 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 RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED AFTER THE UNACCEPTABLE QC RESULTS WERE OBTAINED. THERE HAVE BEEN NO REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877428 ↗
• MalfunctionFeb 29, 2024Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF BIORAD UNASSAYED CONTROL LOT 92950 USING VITROS NA+ SLIDE LOT 4231-1117-4978 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 92950 LEVEL 1 RESULTS OF 134.0 AND 133.5 MMOL/L VS. THE EXPECTED RESULT OF 156.0 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 LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, MULTIPLE UNKNOWN SAMPLES THAT MAY HAVE BEEN PATIENT SAMPLES WERE PROCESSED IN THE TIMEFRAME OF THE EVENT. THE CUSTOMER DID NOT REPORT ANY 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 18807640 ↗
• MalfunctionAug 24, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) SLIDE LOT 4210-1095-5242 AND VITROS POTASSIUM (K+) SLIDE LOT 4102-1101-1047 RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNI CORE (MAS) LOT OCR2511 CONTROL TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MAS LEVEL 1 NA+ RESULTS OF 135.2 AND 167.2 MMOL/L VS. THE EXPECTED RESULT OF 127.7 MMOL/L THE MAS LEVEL 1 K+ RESULT OF 6.69 MMOL/L VS. THE EXPECTED RESULT OF 2.67 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE, HOWEVER, UNKNOWN SAMPLES THAT MAY HAVE BEEN PATIENT SAMPLES WERE PROCESSED IN THE TIMEFRAME OF THE EVENT. THE CUSTOMER DID NOT REPORT ANY ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17613516 ↗
• MalfunctionApr 5, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) QUALITY CONTROL (QC) FLUID USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4246-1076-9008 ON A VITROS 250 CHEMISTRY SYSTEM. VITROS NA+ PV I J9587 RESULTS OF 138.1, 139.0, 139.6, 137.4, AND 136.6 MMOL/L VS. THE EXPECTED RESULT OF 121.4 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. ORTHO HAS NOT BEEN MADE AWARE OF ANY 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 16685617 ↗
• MalfunctionJan 27, 2023High Test Results; High Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS POTASSIUM (K+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROL, LOT 56700 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 1 RESULTS OF 4.38 AND 4.31 MMOL/L, VS. THE EXPECTED RESULT OF 2.60 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 CUSTOMER STATED THAT PATIENT SAMPLE RESULTS WERE AFFECTED BY THE EVENT HOWEVER, NO EXAMPLES OF HIGHER THAN EXPECTED VITROS K+ PATIENT SAMPLE RESULTS WERE PROVIDED BY THE CUSTOMER. IN ADDITION, THE CUSTOMER STATED THAT NO HIGHER THAN EXPECTED VITROS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS 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 600594.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16253894 ↗
• MalfunctionDec 15, 2022Low Test Results; Low Test Results

  A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED SODIUM (NA+) RESULT WAS OBTAINED FROM A COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4241-1072-7737 ON A VITROS 5600 INTEGRATED SYSTEM. CAP CHM-14 RESULT OF 144.0 MMOL/L VS THE EXPECTED RESULT OF 150.8 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 LOWER THAN EXPECTED RESULT WAS FROM A PROFICIENCY SAMPLE. 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 15992000 ↗