Atellica IM VB12 10995715Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00630414600284), received between Jun 28, 2019 and Aug 17, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “High Test Results” (23 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 24 most recent of 24 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 20, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF 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. THE SAME 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 22296381 ↗
• MalfunctionMay 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING VB12 LOT 299. THE CUSTOMER IDENTIFIED A QC FAILURE FOR VB12, AND REPEAT-TESTED SAMPLES FOR WHICH INITIAL RESULTS HAD BEEN REPORTED. FOR ONE SAMPLE, THE INITIAL RESULT WAS MUCH HIGHER THAN THE REPEAT RESULT, AND THE REPEAT RESULT WAS CONSIDERED CORRECT. THERE WAS NO MEDICAL INTERVENTION PERFORMED ON THE BASIS OF THE INITIAL RESULT. THERE ARE NO REPORTS OF PATIENT HARM OR ANY OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975808 ↗
• MalfunctionSep 5, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHILE USING LOT 296. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS TESTED WHILE QUALITY CONTROL (QC) WAS OUT OF RANGE. AS A RESULT, THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER AFTER QC RECOVERED WITHIN LABORATORY ESTABLISHED RANGES AND OBTAINED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. 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 20144526 ↗
• MalfunctionAug 7, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCORDANT ELEVATED MULTIPLE PATIENT(S) SAMPLE RESULTS FOR VITAMIN B12 (VB12) ASSAY, LOT 290 WHEN TESTED WITH ATELLICA IM 1600 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON MULTIPLE ATELLICA IM ANALYZERS AND LOWER RESULTS WERE OBTAINED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED ELEVATED VITAMIN B12 (VB12) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470207 ↗
• MalfunctionJul 10, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM 1600 VITAMIN B12 (VB12) RESULT ON A PATIENT SAMPLE USING LOT 285. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME ATELLICA IM ANALYZER, AND THE RESULT WAS LOWER. THE LOWER RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED VB12 PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288656 ↗
• MalfunctionMay 1, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED QUALITY CONTROL RESULTS WERE POSITIVELY BIASED ON ATELLICA IM VITAMIN B12 (VB12). UPON REPEAT, THE CUSTOMER OBSERVED A PATIENT SAMPLE RESULT THAT WAS ELEVATED COMPARED TO REPEAT TESTING ON A DIFFERENT ATELLICA IM ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM VB12 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843284 ↗
• MalfunctionDec 7, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT FOR ONE PATIENT. THE INITIAL RESULT WAS REPORTED TO PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS TESTED ON ANOTHER ATELLICA IM ANALYZER, AND THE RESULT WAS LOW. 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 15932737 ↗
• MalfunctionSep 2, 2022High Test Results; High Test Results

  THE CUSTOMER IDENTIFIED DISCORDANT (ELEVATED) VITAMIN B12 (VB12) PATIENT RESULTS ON ATELLICA IM 1600 INSTRUMENT # IH00610, REAGENT LOT 280 COMPARED TO LOWER RETEST RESULTS OBTAINED ON A DIFFERENT DAY WITH A DIFFERENT ATELLICA IM INSTRUMENT AND REAGENT LOT. THE CUSTOMER BELIEVES THE REPEAT RESULTS ARE CORRECT. THE INITIAL RESULTS WERE REPORTED TO PHYSICIAN(S) AND WERE QUESTIONED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VB12 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352368 ↗
• MalfunctionSep 1, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED HIGH ATELLICA IM VITAMIN B12 (VB12) RESULTS FOR SAMPLES FROM TWO PATIENTS THAT WERE CONSIDERED DISCORDANT WHEN COMPARED TO THE LOWER REPEAT RESULTS ON THE OTHER ATELLICA IM ANALYZERS AT THE CUSTOMER SITE. THE SAMPLES WERE REPEATED DUE TO THE QUALITY CONTROL (QC) RESULTS WERE OUT OF RANGE HIGH FOR THE VITAMIN B12 (VB12) ASSAY ON THE ATELLICA IM S/N IH00575. THE INITIAL RESULTS WERE RUN ON ATELLICA IM S/N IH00575 WITH LOT 280 AND WERE CONSIDERED DISCORDANT. THE REPEAT TESTING FOR SID (B)(6) WAS RUN ON ATELLICA IM S/N (B)(4) WITH LOT 280 AND WAS CONSIDERED CORRECT. THE REPEAT TESTING FOR SID (B)(6) WAS RUN ON ATELLICA IM S/N (B)(4)WITH LOT 282 AND WAS CONSIDERED CORRECT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VITAMIN B12 (VB12) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334631 ↗
• MalfunctionAug 18, 2022High Test Results; High Test Results

  THE CUSTOMER IDENTIFIED DISCORDANT (ELEVATED) ATELLICA IM VITAMIN B12 (VB12) PATIENT RESULTS AFTER QUALITY CONTROL (QC) VALUES SHOWED A DROP IN RESULTS AND PATIENTS WERE SUBSEQUENTLY RETESTED ON DIFFERENT ATELLICA IM INSTRUMENTS. RESULTS WERE LOWER UPON REPEAT. THE CUSTOMER BELIEVES THE REPEAT RESULTS ARE CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED VB12 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15252750 ↗
• MalfunctionMay 26, 2022High Test Results; High Test Results

  ONE FALSELY ELEVATED VITAMIN B12 (VB12) TEST RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE FROM AN ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS RELEASED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME ATELLICA IM 1600 ANALYZER AND THE RESULT WAS LOWER. THE REPEAT RESULT WAS RELEASED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED VITAMIN B12 TEST RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516666 ↗
• MalfunctionDec 13, 2021High Test Results; High Test Results

  THE CUSTOMER HAS OBSERVED AN INITIAL ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT FOR A PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT-TEST RESULTS USING THE SAME METHOD. THE FALSELY-ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED, DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12989305 ↗
• MalfunctionSep 28, 2021High Test Results; High Test Results

  AN INITIAL VITAMIN B12 (VB12) RESULT FOR A PATIENT WAS GENERATED ON AN ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED IN DUPLICATE ON THE SAME ATELLICA IM 1600 ANALYZER AND BOTH REPLICATES WERE CONSIDERED DISCORDANT, FALSELY ELEVATED RESULTS. THE SAMPLE WAS SENT OUT TO AN ALTERNATE FACILITY FOR TESTING AND RESULTED 120 PMOL/L WHICH WAS REPORTED TO THE PHYSICIAN(S), AS THE CORRECT RESULT. THE INITIAL RESULT WAS ALSO CONSIDERED CORRECT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED, DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540070 ↗
• MalfunctionJun 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSELY ELEVATED RESULT WAS OBTAINED USING THE ATELLICA IM VITAMIN B12 (VB12) ASSAY AND WAS REPORTED TO THE PHYSICIAN. IT IS UNKNOWN IF THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED IN TRIPLICATE USING 2 DIFFERENT ATELLICA IM INSTRUMENTS. THE CUSTOMER ISSUED A CORRECTED REPORT TO PHYSICIAN, AVERAGING THE THREE REPEAT REPLICATES. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED AND NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED ATELLICA IM VB12 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8746334 ↗