Syva® Emit® 2000 Tacrolimus Assay 10445397Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00842768001666), received between Mar 25, 2022 and Oct 2, 2024 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (28 reports).

1 other recall cover devices cleared under the same FDA submission (K060385); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356256 ↗
• MalfunctionOct 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355758 ↗
• MalfunctionOct 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). ADDITIONALLY, THE CUSTOMER REPORTED THE OBSERVATION OF A QUALITY CONTROL (QC) FAILURE ON THIS EVENT DATE. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OR QC FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355665 ↗
• MalfunctionOct 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355643 ↗
• MalfunctionOct 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355640 ↗
• MalfunctionOct 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355633 ↗
• MalfunctionOct 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OBTAINED ON PATIENT SAMPLES ON A VIVA-PROE ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULTS WERE CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). ADDITIONALLY, THE CUSTOMER REPORTED THE OBSERVATION OF A QUALITY CONTROL (QC) FAILURE ON THIS EVENT DATE. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OR QC FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355632 ↗
• MalfunctionOct 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OBTAINED ON PATIENT SAMPLES ON A VIVA-PROE ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULTS WERE CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). ADDITIONALLY, THE CUSTOMER REPORTED THE OBSERVATION OF A QUALITY CONTROL (QC) FAILURE ON THIS EVENT DATE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OR QC FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355608 ↗
• MalfunctionOct 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355606 ↗
• MalfunctionOct 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355594 ↗
• MalfunctionOct 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OBTAINED ON PATIENT SAMPLES ON A VIVA-PROE ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULTS WERE CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355512 ↗
• MalfunctionOct 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355499 ↗
• MalfunctionOct 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED CORRECT OR REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355496 ↗
• MalfunctionOct 2, 2024Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED NON-REPRODUCIBLE SYVA® EMIT ® 2000 TACROLIMUS RESULTS FOR MULTIPLE PATIENT SAMPLES ON THE VIVA-E® ANALYZER WHEN USING TACROLIMUS LOTS S3 AND S4. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH RESULT IS CONSIDERED CORRECT. IT IS UNKNOW IF THE PATIENTS WERE TAKING TACROLIMUS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-REPRODUCIBLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353078 ↗
• MalfunctionOct 2, 2024Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED NON-REPRODUCIBLE SYVA® EMIT ® 2000 TACROLIMUS RESULTS FOR MULTIPLE PATIENT SAMPLES ON THE VIVA-E® ANALYZER WHEN USING TACROLIMUS LOTS S3 AND S4. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH RESULT IS CONSIDERED CORRECT. IT IS UNKNOWN IF THE PATIENTS WERE TAKING TACROLIMUS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-REPRODUCIBLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352894 ↗
• MalfunctionFeb 6, 2024Low Test Results; Low Test Results

  FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A VIVA-PROE SYSTEM. RESULTS WERE INCONSISTENT WITH HISTORICAL RESULTS. FOR SOME OF THE PATIENT SAMPLES THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND IT IS UNKNOWN IF THE PHYSICIAN(S) QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. A CORRECTED REPORT WAS ISSUED. ADDITIONALLY QUALITY CONTROL (QC) DRIFT OVERTIME WAS OBSERVED. EVENTUALLY THE QC FAILED LOW AND THE CUSTOMER RECALIBRATED AND/OR REPEATED THE QC IN ORDER TO OBTAIN IN RANGE QC RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OR THE QC FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18653729 ↗
• MalfunctionFeb 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED SYVA® EMIT ® 2000 TACROLIMUS RESULTS FOR MULTIPLE PATIENT SAMPLES ON THE VIVA-E® ANALYZER, THAT WERE CONSIDERED ERRONEOUS TO REPEAT TESTING ON THE SAME ANALYZER. ONLY RESULTS CONSIDERED CORRECT BY THE LABORATORY WERE REPORTED TO THE PHYSICIAN(S). ADDITIONALLY QUALITY CONTROL (QC) RECOVERED WITHIN RANGE AFTER REPROCESSING SEVERAL TIMES. PATIENT SAMPLES WERE NOT PROCESSED WHEN QC WAS OUT OF RANGE. PATIENT RESULTS WERE REPORTED ONLY WHEN QC WAS IN RANGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632048 ↗
• MalfunctionFeb 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED SYVA® EMIT ® 2000 TACROLIMUS RESULTS FOR MULTIPLE PATIENT SAMPLES ON THE VIVA-E® ANALYZER, THAT WERE CONSIDERED ERRONEOUS TO REPEAT TESTING ON THE SAME ANALYZER. ONLY RESULTS CONSIDERED CORRECT BY THE LABORATORY WERE REPORTED TO THE PHYSICIAN(S). ADDITIONALLY QUALITY CONTROL (QC) RECOVERED WITHIN RANGE AFTER REPROCESSING SEVERAL TIMES. PATIENT SAMPLES WERE NOT PROCESSED WHEN QC WAS OUT OF RANGE. PATIENT RESULTS WERE REPORTED ONLY WHEN QC WAS IN RANGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630902 ↗
• MalfunctionFeb 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED SYVA® EMIT ® 2000 TACROLIMUS RESULTS FOR MULTIPLE PATIENT SAMPLES ON THE VIVA-E® ANALYZER, THAT WERE CONSIDERED ERRONEOUS TO REPEAT TESTING ON THE SAME ANALYZER. ONLY RESULTS CONSIDERED CORRECT BY THE LABORATORY WERE REPORTED TO THE PHYSICIAN(S). ADDITIONALLY QUALITY CONTROL (QC) RECOVERED WITHIN RANGE AFTER REPROCESSING SEVERAL TIMES. PATIENT SAMPLES WERE NOT PROCESSED WHEN QC WAS OUT OF RANGE. PATIENT RESULTS WERE REPORTED ONLY WHEN QC WAS IN RANGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630346 ↗
• MalfunctionFeb 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED SYVA® EMIT ® 2000 TACROLIMUS RESULTS FOR MULTIPLE PATIENT SAMPLES ON THE VIVA-E® ANALYZER, THAT WERE CONSIDERED ERRONEOUS TO REPEAT TESTING ON THE SAME ANALYZER. ONLY RESULTS CONSIDERED CORRECT BY THE LABORATORY WERE REPORTED TO THE PHYSICIAN(S). ADDITIONALLY QUALITY CONTROL (QC) RECOVERED WITHIN RANGE AFTER REPROCESSING SEVERAL TIMES. PATIENT SAMPLES WERE NOT PROCESSED WHEN QC WAS OUT OF RANGE. PATIENT RESULTS WERE REPORTED ONLY WHEN QC WAS IN RANGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630341 ↗
• MalfunctionJan 29, 2024Low Test Results; Low Test Results

  FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A VIVA-PROE SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RUN IN DUPLICATE ON THE SAME INSTRUMENT. THE CORRECT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). ADDITIONALLY QUALITY CONTROL (QC) DRIFT OVERTIME WAS OBSERVED. EVENTUALLY THE QC FAILED LOW AND THE CUSTOMER RECALIBRATED AND/OR REPEATED THE QC IN ORDER TO OBTAIN IN RANGE QC RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OR THE QC FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18601619 ↗
• MalfunctionJan 29, 2024Low Test Results; Low Test Results

  FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A VIVA-PROE SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). ADDITIONALLY QUALITY CONTROL (QC) DRIFT OVERTIME WAS OBSERVED. EVENTUALLY THE QC FAILED LOW AND THE CUSTOMER RECALIBRATED AND/OR REPEATED THE QC IN ORDER TO OBTAIN IN RANGE QC RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OR THE QC FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18601605 ↗
• MalfunctionJan 29, 2024Low Test Results; Low Test Results

  FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A VIVA-PROE SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. SOME SAMPLES WERE REPEATED MORE THAN ONCE. THE CORRECT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULT(S). THE HIGHEST RESULTS WERE REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). ADDITIONALLY QUALITY CONTROL (QC) DRIFT OVERTIME WAS OBSERVED. EVENTUALLY THE QC FAILED LOW AND THE CUSTOMER RECALIBRATED AND/OR REPEATED THE QC IN ORDER TO OBTAIN IN RANGE QC RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULTS OR THE QC FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18601463 ↗
• MalfunctionJan 29, 2024Low Test Results; Low Test Results

  A FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). ADDITIONALLY QUALITY CONTROL (QC) DRIFT OVERTIME WAS OBSERVED. EVENTUALLY THE QC FAILED LOW AND THE CUSTOMER RECALIBRATED AND/OR REPEATED THE QC IN ORDER TO OBTAIN IN RANGE QC RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OR THE QC FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18601394 ↗
• MalfunctionJan 29, 2024Low Test Results; Low Test Results

  A FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). ADDITIONALLY QUALITY CONTROL (QC) DRIFT OVERTIME WAS OBSERVED. EVENTUALLY THE QC FAILED LOW AND THE CUSTOMER RECALIBRATED AND/OR REPEATED THE QC IN ORDER TO OBTAIN IN RANGE QC RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SYVA® EMIT® 2000 TACROLIMUS ASSAY RESULT OR THE QC FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18601320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060385. One submission often covers many models, so check the product and lot details in each record.

• Z-1661-2018 · Jun 29, 2017 · Terminated
  Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)