Atellica IM VB12Recalls & reported problems across all models

We found 2 models of Atellica IM VB12 by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2019 and Aug 17, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “High Test Results” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Atellica IM VB12 problems

Atellica IM VB12 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Atellica IM VB12 10995715

  RADIOASSAY, VITAMIN B12
  24 reports
• Atellica IM VB12 10995714

  RADIOASSAY, VITAMIN B12
  13 reports

Recent Atellica IM VB12 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286943 ↗
• MalfunctionAug 8, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50185056 ↗
• MalfunctionApr 9, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WITH LOT # 302, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON THE ALTERNATE ANALYZER. THE CUSTOMER USES TWO PARAMETERS SUCH AS MOVING AVERAGE CONCEPT AND QUALITY CONTROL (QC) FOR ASSAY PERFORMANCE. ON THE DAY OF THE RESET, TWO MOVING AVERAGE FAILURES WITH NEGATIVE BIAS WERE OBSERVED. ALSO OBSERVED FAILED QC RESULTS ON ANCILLARY PACK OF 5446 AND 5562. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT AND MATCHED THE CLINICAL ASSESSMENT. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24825320 ↗
• MalfunctionMar 5, 2026High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12, LOT# 302) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER, WHICH YIELDED A LOWER RESULT. THE LOWER RETESTED RESULT MATCHED THE PATIENT¿S CLINICAL ASSESSMENT AND WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520390 ↗
• MalfunctionMar 5, 2026High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12, LOT# 302) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER, WHICH YIELDED A LOWER RESULT. THE LOWER RETESTED RESULT MATCHED THE PATIENT¿S CLINICAL ASSESSMENT AND WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520089 ↗
• MalfunctionJan 20, 2026High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF ELEVATED ATELLICA IM VITAMIN B12 (VB12, LOT# 302) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER, WHICH YIELDED A LOWER RESULT. THE LOWER RETESTED RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112767 ↗
• MalfunctionOct 28, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF ELEVATED ATELLICA IM VITAMIN B12 (VB12, LOT#: 300) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL ABOVE-ASSAY RANGE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). FOLLOWING THE ABOVE-ASSAY RANGE RESULT, THE CUSTOMER DID NOT PERFORM A DILUTION AS PROVIDED IN THE INSTRUCTIONS FOR USE (IFU) BECAUSE THE DILUENT WAS NOT AVAILABLE ONBOARD THE ANALYZER. SUBSEQUENTLY, THE SAMPLE WAS RETESTED AFTER RE-CENTRIFUGATION ON AN ALTERNATE ATELLICA IM 1300 ANALYZER FOR TROUBLESHOOTING PURPOSES, WHICH YIELDED THE SAME ELEVATED RESULT. THE SAMPLE WAS THEN RETESTED ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM, YIELDING A LOWER RESULT THAN THE PREVIOUS RESULTS. THIS LOWER RETESTED RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). ADDITIONALLY FOR TROUBLESHOOTING PURPOSES, THE SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER, AN ALTERNATE ATELLICA IM 1300 ANALYZER, AND AN ALTERNATE DIMENSION VISTA 1500 SYSTEM, ALL OF WHICH YIELDED LOWER RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400475 ↗
• MalfunctionOct 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN USING REAGENT LOT 300 ON AN ATELLICA IM 1300 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER RE-CENTRIFUGED THE SAMPLE AND REPEATED ON AN ALTERNATE ATELLICA ANALYZER AND OBTAINED THE SAME RESULT OF >2000 PG/ML. THE SAMPLE WAS AGAIN REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND OBTAINED A RESULT, WHICH WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER THEN REPEATED THE SAMPLES AFTER RESTING THE SAMPLE, THE RESULTS OF 202, 224 WERE OBTAINED ON THE ATELLICA ANALYZER AND 156 ON THE DIMENSION VISTA INSTRUMENT. THESE RESULTS WERE FOR TROUBLESHOOTING PURPOSES ONLY. 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 23321122 ↗
• MalfunctionSep 19, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF OUT-OF-RANGE QUALITY CONTROL (QC) RESULTS AND AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING REAGENT LOT# 299. AN INITIAL ELEVATED VB12 RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. DUE TO QC BEING OUT OF RANGE, THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER AND OBTAINED A LOWER RESULT, WHICH WAS CONSIDERED CORRECT AND ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093372 ↗
• MalfunctionAug 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS DISCORDANT ELEVATED VITAMIN B12 (VB12) PATIENT RESULTS USING REAGENT LOT 300 ON ATELLICA IM ANALYZER #(B)(4). THE DISCORDANCE WAS IDENTIFIED AFTER A QUALITY CONTROL MOVING AVERAGE VIOLATION (>2SD DEVIATION) WAS OBSERVED AND PATIENT SAMPLES WERE RETESTED ON DIFFERENT ATELLICA IM ANALYZERS. NO CALIBRATION ISSUES WERE IDENTIFIED. THERE IS NO REPORT OF PHYSICIANS QUESTIONING THE RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879065 ↗
• MalfunctionAug 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS DISCORDANT ELEVATED VITAMIN B12 (VB12) PATIENT RESULTS USING REAGENT LOT 300 ON ATELLICA IM ANALYZER # (B)(6). THE DISCORDANCE WAS IDENTIFIED AFTER A QUALITY CONTROL MOVING AVERAGE VIOLATION (>2SD DEVIATION) WAS OBSERVED AND PATIENT SAMPLES WERE RETESTED ON DIFFERENT ATELLICA IM ANALYZERS. NO CALIBRATION ISSUES WERE IDENTIFIED. THERE IS NO REPORT OF PHYSICIANS QUESTIONING THE RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874209 ↗
• MalfunctionAug 22, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED VITAMIN B12 (VB12) PATIENT RESULT USING REAGENT LOT 299 ON ATELLICA IM ANALYZER # (B)(6). THE PATIENT SAMPLE DISCORDANCE WAS IDENTIFIED AFTER (MOVING AVERAGE VIOLATION) UNSATISFACTORY VALUES FOR CUSTOMER METRICS (MOVING AVERAGE VIOLATION) WAS OBSERVED AND THE PATIENT SAMPLE WAS RETESTED ON DIFFERENT ATELLICA IM ANALYZER. NO CALIBRATION ISSUES WERE IDENTIFIED. THERE IS NO REPORT OF PHYSICIANS QUESTIONING RESULTS. THERE IS NO ALLEGATION OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874207 ↗
• MalfunctionAug 19, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES WHEN USING REAGENT LOT 300 ON AN ATELLICA IM 1300 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE NOT REPEATED BECAUSE THE SAMPLES WERE DISCARDED BY THE TIME THE PHYSICIAN CALLED THE LAB. THE CUSTOMER CONFIRMED THAT THE PATIENTS WERE NOT REDRAWN. THE CORRECT RESULTS ARE UNKNOWN FOR THESE SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED VB12 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839205 ↗
• MalfunctionAug 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING REAGENT LOT # 299. INITIAL ELEVATED VITAMIN B12 (VB12) RESULTS WERE OBTAINED TWO PATIENT SAMPLES. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. HOWEVER, THE SAME SAMPLES WERE REPEATED ON THE ORIGINAL ANALYZER BECAUSE THE CUSTOMER INDICATED THAT THE VB12 ANCILLARY REAGENT WAS IMPROPERLY PREPARED; INSTEAD OF THE REQUIRED 12 ML OF RELEASING AGENT, ONLY 4 ML WAS USED. THE REPEAT RESULTS RECOVERED LOWER, WHICH WERE CONSIDERED CORRECT, AND CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22780537 ↗
• MalfunctionJul 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULT ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUSLY ELEVATED RESULT WAS OBTAINED WHEN QUALITY CONTROL (QC) RECOVERED OUT-OF-RANGE. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON ALTERNATE ATELLICA IM 1600 ANALYZER. THE LOWER REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS NOT ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402671 ↗

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