Atellica IM VB12 10995714Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00630414600277), received between Aug 23, 2021 and Oct 28, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (13 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, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionMay 29, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCORDANT ATELLICA IM (#IH00597) VITAMIN B12 (VB12) LOT 298 RESULTS COMPARED TO REPEAT TESTING PERFORMED ON ANOTHER ATELLICA IM ANALYZER (#IRH01068). THE ISSUE WAS IDENTIFIED WHEN QUALITY CONTROL (QC) WAS FOUND TO BE HIGH OUT OF RANGE AFTER A GROUP OF PATIENT SAMPLE TESTING WAS COMPLETED. THE PATIENT SAMPLES WERE THEN RETESTED ON A DIFFERENT ATELLICA IM ANALYZER WHERE QC WAS IN RANGE AND A NUMBER OF THE RETESTED SAMPLES SHOWED A DISCORDANCE BETWEEN THE INITIAL RESULTS (NORMAL RANGE) AND THE RETEST RESULTS (DEFICIENT RANGE). THE RETEST RESULTS WERE CONSIDERED CORRECT. 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 22109098 ↗
• MalfunctionMay 27, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF DISCORDANT ELEVATED ATELLICA IM VITAMIN B12 (VB12, LOT: 298) RESULTS ON TWO PATIENT SAMPLES ON AN ATELLICA CI 1900 ANALYZER. THE INITIAL ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE (B)(6) WAS REPEATED THRICE ON THE SAME ATELLICA CI 1900 ANALYZER. THE RESULTS OBTAINED WERE RELATIVELY LOWER, BUT THE CUSTOMER WAS UNABLE TO DETERMINE THE CORRECT RESULT. THE REPEAT RESULTS WERE NOT REPORTED, AND THE CUSTOMER STATED THAT THEY WILL REDRAW THE SAMPLES AND RETEST FOR THE CORRECT RESULT. FOR SAMPLE ID: (B)(6), THE CUSTOMER DID NOT PERFORM ANY REPEAT TESTING, AND THE CORRECT RESULT IS UNKNOWN. 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 22086204 ↗
• MalfunctionMay 2, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS CONSIDERED DISCORDANT WHEN USING REAGENT LOT# 297. AN INITIAL ELEVATED (>1000 PG/ML) RESULT WAS OBTAINED. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. HOWEVER, THE CUSTOMER DID NOT REPEAT TEST THE SAMPLE AND THE CORRECT RESULT IS UNKNOWN. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948424 ↗
• MalfunctionApr 25, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) WHICH WAS CONSIDERED DISCORDANT WHEN USING REAGENT LOT# 296. AN INITIAL ELEVATED VB12 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. HOWEVER, THE CUSTOMER DID NOT REPEAT TEST THE SAMPLE AND THE CORRECT RESULT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF DELAY, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907392 ↗
• MalfunctionApr 25, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) WHICH WAS CONSIDERED DISCORDANT WHEN USING REAGENT LOT# 296. AN INITIAL ELEVATED VB12 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. HOWEVER, THE CUSTOMER DID NOT REPEAT TEST THE SAMPLE AND THE CORRECT RESULT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF DELAY, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907376 ↗
• MalfunctionJan 5, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT FOR THREE PATIENT SAMPLES. THE INITIAL RESULTS WERE NOT REPORTED TO PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE TESTED ON ANOTHER ATELLICA IM ANALYZER, AND THE RESULTS WERE LOWER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VITAMIN B12 (VB12) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102203 ↗
• MalfunctionDec 17, 2021High Test Results; High Test Results

  CUSTOMER OBSERVED AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT FOR A PATIENT SAMPLE COMPARED TO THE REPEAT RESULT AND HISTORICAL RESULTS. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024551 ↗
• MalfunctionAug 23, 2021High Test Results; High Test Results

  THE CUSTOMER OBTAINED A HIGH ATELLICA IM VB12 RESULT FOR A PATIENT SAMPLE THAT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE LOWER REPEAT RESULT ON ANOTHER ATELLICA IM AT THE CUSTOMER SITE. THE PATIENT SAMPLE WAS REPEATED DUE TO THE QUALITY CONTROL (QC) RESULTS WERE OUT OF RANGE HIGH FOR THE VB12 ASSAY ON THE ATELLICA IM SERIAL NO.: (B)(4). A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VB12 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354024 ↗