Atellica CH TACR 11097542Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414238340), received between Dec 14, 2023 and Sep 15, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Low Test Results

  The customer reported that they obtained erroneously depressed Tacrolimus (TACR) results on two patient samples on an Atellica CH 930 Analyzer.The initial results were reported to the physician(s) and were questioned. The samples were repeated on an alternate Atellica CH 930 Analyzer, and the results recovered higher than the initial results and were considered correct. Corrected reports were issued with the repeat results. There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed TACR results.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771391 ↗
• MalfunctionFeb 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED DISCORDANT TACROLIMUS (TACR) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TACROLIMUS (TACR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444007 ↗
• MalfunctionDec 14, 2023High Test Results; Low Test Results; High Test Results; Low Test Results

  DISCORDANT ELEVATED TACROLIMUS (TACR) RESULTS WERE OBTAINED ON SAMPLES FROM TWO PATIENTS ON AN ATELLICA CH 930 INSTRUMENT (S/N(B)(6)). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME ATELLICA CH 930 INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULTS. CORRECTED REPORT(S) WERE ISSUED. THE PATIENTS WERE BOTH ORGAN TRANSPLANT RECIPIENTS. THERE ARE NO KNOWN REPORTS ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TACROLIMUS (TACR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325509 ↗
• MalfunctionDec 14, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED AN ABOVE ASSAY RANGE RESULT FOR TACROLIMUS (TACR) ON A PATIENT SAMPLE WHEN PROCESSED ON AN ATELLICA CH 930 INSTRUMENT (S/N (B)(6)). THE PATIENT SAMPLE WAS DILUTED AND REPEATED. THE RESULTS WERE LOWER AND WITHIN THE ASSAY RANGE. THE LOWER DILUTED RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE RESULT WAS HIGHER AND CONSIDERED TOXIC. THE INITIAL SAMPLE WAS REPEATED AND THE NEAT RESULT WAS SIMILAR TO THE NEW SAMPLE RESULT. THE PATIENT IS AN ORGAN TRANSPLANT RECIPIENT AND WAS GIVEN TACROLIMUS TREATMENT. THE TRANSPLANT TIME FRAME WAS NOT PROVIDED FOR THE PATIENT. THERE ARE NO KNOWN REPORTS ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TACROLIMUS (TACR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325390 ↗

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)