Elecsys Vitamin B12 II 07028121190Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04015630939848), received between Jun 6, 2022 and Sep 25, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896784 ↗
• MalfunctionSep 16, 2026High Test Results; High Readings

  We received an allegation about discrepant results for 1 patient sample tested with Elecsys Vitamin B12 II assay on a cobas 8000 e 801 module.Initial result: 756. No questionable result was reported outside the laboratory, and the sample was repeated on a different module.Repeat result: 364.The unit of measurement was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792414 ↗
• MalfunctionMar 18, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A SAMPLE MISMATCH WHILE USING THE COBAS PRO SSU ANALYZER. THE CUSTOMER MANUALLY PROGRAMMED A SAMPLE FOR SODIUM AND SERUM INDICES USING THE PATIENT'S NAME AS THE SAMPLE ID (B)(6). HOWEVER, WHEN THE SAMPLE WAS LOADED ON THE ANALYZER, IT POPULATED A DIFFERENT PATIENT NAME AND A VITAMIN B12 TEST WAS ADDED. WHEN THE RACK WAS LOADED, THE SYSTEM REGISTERED THE SAMPLE WITH A PREVIOUS PATIENT'S SAMPLE ID, (B)(6). THE RESULT FOR VITAMIN B12 WAS 1376 PG/ML. MULTIPLE OTHER PATIENT SAMPLES WERE MANUALLY PROGRAMMED, AND THOSE ALL RAN APPROPRIATELY. THE SUSPECT SAMPLE WAS THEN MANUALLY REPROGRAMMED IN THE SAME MANNER, EXCEPT IT WAS PROGRAMMED TO RUN IN A DIFFERENT POSITION ON THE SAME RACK (RACK S40012-4). THE SAMPLE THEN RAN CORRECTLY. THE RESULT FOR VITAMIN B12 WAS 325 PG/ML. NO RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628275 ↗
• MalfunctionAug 8, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN B12 II (B12 II) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS < 100 PG/ML WITH A DATA FLAG. ON (B)(6) 2025, THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS REPEATED WITH A RESULT OF 402 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751459 ↗
• MalfunctionJul 10, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS VITAMIN B12 ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A VITAMIN B12 VALUE OF < 150 PG/ML. THE VALUE WAS QUESTIONED BY THE DOCTOR SINCE IT DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER, RESULTING IN A VITAMIN B12 VALUE OF 427 PG/ML. THE REPEAT VALUE WAS DEEMED CORRECT. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A VITAMIN B12 VALUE OF 293 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467549 ↗
• MalfunctionMay 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Chemical Problem; Device Ingredient or Reagent Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Chemical Problem; Device Ingredient or Reagent Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 II RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULTS ARE BELOW 100 PG/ML. UPON REPEATING THE SAMPLES ON ANOTHER E801 ANALYZER, THE RESULTS ARE NOT BELOW 100 PG/ML. ONE RESULT WAS 427 PG/ML, THE OTHER RESULTS ARE BETWEEN 200 PG/ML AND 300 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113586 ↗
• MalfunctionMar 21, 2025Low Readings; Non Reproducible Results; Low Readings; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS VITAMIN B12 G2 (VITAMIN B12 II) ASSAY ON A COBAS PURE E402 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 350 PG/ML. REPEAT RESULT: 669 PG/ML. SAMPLE 2: INITIAL RESULT: 100 PG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 237 PG/ML. SAMPLE 3 AND SAMPLE 4 WERE TESTED ON (B)(6)2025: SAMPLE 3: INITIAL RESULT: 214 PG/ML. REPEAT RESULT: 375 PG/ML. SAMPLE 4: INITIAL RESULT: 224 PG/ML. REPEAT RESULT: 419 PG/ML. THE CUSTOMER HAD CALIBRATION AND QC ISSUES PROMPTING THE REPEAT OF THE SAMPLES IN ANOTHER LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662738 ↗
• MalfunctionJan 29, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED THEY RECEIVED A QUESTIONABLY HIGH ELECSYS VITAMIN B12 II ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS PURE E 402 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A VITAMIN B12 VALUE OF 535 PG/ML. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 176 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266210 ↗
• MalfunctionNov 27, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE. THE INITIAL VITAMIN B12 RESULT WAS <0.1 UG/ML. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 0.35 UG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797575 ↗
• MalfunctionNov 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 II RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 100 PG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED AND THE RESULT WAS 100 PG/ML WITH A DATA FLAG. A 1:2 DILUTION WAS PERFORMED AND THE RESULT WAS 200 PG/ML WITH A DATA FLAG. A 1:10 DILUTION WAS PERFORMED AND THE RESULT WAS 1000 PG/ML WITH A DATA FLAG. ON (B)(6) 2024, THE REPEATED RESULT WAS 100 PG/ML WITH A DATA FLAG A 1:50 DILUTION WAS PERFORMED AND THE RESULT WAS 104 PG/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. PATIENT 2: ON (B)(6) 2024, THE INITIAL RESULT WAS 100 PG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH AN ONBOARD DILUTION (1:10) ON ANOTHER MODULE AND THE RESULT WAS >1476 PG/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. A MANUAL 1:5 DILUTION WAS PERFORMED AND THE RESULT WAS 500 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789485 ↗
• MalfunctionSep 9, 2024Low Test Results; Output Problem; Non Reproducible Results; Low Test Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO SSU E 801 MODULE. ON (B)(6) 2024, THE INITIAL VITAMIN B12 RESULT WAS 101 PG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 100 PG/ML WITH FLAG. THE RESULTS WERE DEEMED INCORRECT. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON AN E601 ANALYZER. THE INITIAL VITAMIN B12 RESULT WAS 201.8 PG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 178.4 PG/ML. THE RESULT OF 201.8 PG/ML WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170210 ↗
• MalfunctionSep 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 II RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 146 PMOL/L. ON (B)(6) 2024, THE SAME SAMPLE WAS TESTED WITH A NEW REAGENT CASSETTE AND A NEW CALIBRATION WITH A RESULT OF 255 PMOL/L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148758 ↗
• MalfunctionJul 11, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN B12 II (B12 II) RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER STATED THAT THE CLINICIAN ASKED IF KNOWN INTERFERENCE FACTORS WERE PRESENT BECAUSE THE RESULTS WERE TOO HIGH AND DID NOT MATCH THE CLINICAL PICTURE FOR PERNICIOUS ANEMIA. ON (B)(6) 2024: THE RESULT WAS 977 NG/L. ON (B)(6) 2024: THE RESULT WAS 1082 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719188 ↗
• MalfunctionMay 24, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN B12 II (B12 II) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <100 PG/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE CLINICIAN DID NOT AGREE WITH THE RESULT AS IT WAS NOT CONSISTENT WITH THE PATIENT¿S PRIOR RESULT. THE REPEAT RESULT WAS 1388 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19394724 ↗
• MalfunctionMar 20, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE VITAMIN B12 G2 ELECSYS E2G RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 150 PG/ML WITH A DATA FLAG. THE SAMPLE WAS TESTED ON ANOTHER ANALYZER AND THE RESULT WAS AROUND 270 PG/ML. THEY REPEATED THE SAMPLE ON BOTH ANALYZERS AND RECEIVED SIMILAR RESULTS. NO SPECIFIC DATA WAS PROVIDED. THE CUSTOMER REPEATED THE SAMPLE USING A STANDBY PACK OF THE REAGENT AND THE RESULT WAS 263 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944816 ↗
• MalfunctionJan 18, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM/PLASMA SAMPLE TESTED WITH ELECSYS VITAMIN B12 G2 (VITAMIN B12 II) ASSAY ON A COBAS PURE SAMPLE SUPPLY UNIT. INITIAL RESULT: 107 PG/ML. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AS THE CUSTOMER NOTICED THAT THE RESULT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 318 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18537914 ↗
• MalfunctionDec 20, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2023, THE INITIAL B12 RESULT WAS 1693 PG/ML. THE DOCTOR QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. ON (B)(6) 2023, A NEW SAMPLE WAS COLLECTED AND THE RESULT WAS 1636 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363318 ↗
• MalfunctionNov 3, 2023High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN B12 II (VITAMIN B12 II) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THE RESULT FROM THE E801 ANALYZER WAS 983 PMOL/L. THE SAMPLE WAS TESTED BY A COMPETITOR METHOD AND THE RESULT WAS 366 PG/ML (270.12 PMOL/L).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067340 ↗
• InjuryMar 30, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF HIGH VITAMIN B12 G2 ELECSYS RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT SERIAL NUMBER (B)(4) FOR 1 PATIENT WHICH REPORTEDLY LED TO A BONE MARROW ASPIRATION. THE INITIAL RESULT WAS REPORTEDLY 1476 PMOL/L WITH A DATA FLAG AND WAS REPORTED OUTSIDE OF THE LABORATORY. A NEW SAMPLE WAS DRAWN AND THE RESULT WAS REPORTEDLY 1476 PMOL/L WITH A DATA FLAG. AFTER THE FIRST RESULTS, A BONE MARROW ASPIRATION WAS REPORTEDLY PERFORMED TO TRY TO UNDERSTAND THE PATHOLOGY. THE ASPIRATION ALLEGEDLY "WENT WELL AND THE RESULT WAS OK". ON (B)(6) 2023, ONE OF THE SAMPLES WAS RETESTED AT AN EXTERNAL LABORATORY ON A COBAS E801 ANALYZER AND THE RESULT WAS <111 PMOL/L. ON (B)(6) 2023, THE OTHER SAMPLE WAS RETESTED ON A COBAS E801 ANALYZER AT THE EXTERNAL LABORATORY AND THE RESULT WAS <111 PMOL/L. ALLEGEDLY, THE PATIENT WOULD HAVE BEEN TREATED WITH B12 SUPPLEMENTATION INSTEAD OF UNDERGOING A BONE MARROW ASPIRATION.

  Patient problems: Insufficient Information

  MAUDE report 16645606 ↗
• MalfunctionJul 19, 2022Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FOR SEVERAL PATIENT SAMPLES TESTED ON AN UNSPECIFIED COBAS 8000 ANALYZER WITH AN UNKNOWN SERIAL NUMBER. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022, THE REPORTER NOTICED THAT THE VITAMIN B12 RESULTS WERE LOW AND WERE NOT CONFIRMED BY THE HOLOTRANSCOBALAMIN OR METHYLMALONIC ACID (MMA) MEASUREMENT. THE REPORTER SENT THE SAMPLES TO ANOTHER LABORATORY THAT USED THE SAME REAGENT AND CALIBRATOR LOT. ON (B)(6) 2022, THE CUSTOMER USED A SECOND REAGENT LOT AND RERAN THE SAMPLES ON THE ANALYZER. SAMPLE 3 WAS ALSO RERUN ON ANOTHER COBAS ANALYZER. THE VITAMIN B12 RESULTS WERE AS EXPECTED AND WERE COMPATIBLE WITH HOLOTRANSCOBALAMIN. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES: SAMPLE 1'S INITIAL RESULT FROM THE ANALYZER WAS 124 PMOL/L. THE FIRST REPEAT RESULT FROM THE OTHER LABORATORY WAS 174 PMOL/L. THE SECOND REPEAT RESULT FROM THE ANALYZER USING THE SECOND REAGENT LOT WAS 150 PMOL/L. THE THIRD REPEAT RESULT FROM THE ANALYZER USING THE SECOND REAGENT LOT WAS 131 PMOL/L. SAMPLE 2'S INITIAL RESULT FROM THE ANALYZER WAS 110 PMOL/L. THE REPEAT RESULT FROM T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053480 ↗
• MalfunctionJun 6, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THAT ON (B)(6) 2022, CALIBRATION AND CONTROLS WERE OUT OF LIMITS AFTER LOADING A NEW ELECSYS VITAMIN B12 GEN. 2 IMMUNOASSAY REAGENT PACK ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER (B)(4). AFTER SEVERAL ATTEMPTS AT RUNNING CALIBRATION AND CONTROLS, THE ASSAY WAS CHANGED TO THE SECOND MEASURING CHANNEL OF THE ANALYZER AND CONTROLS RECOVERED NEAR THE TARGET. ON (B)(6) 2022, THE CUSTOMER MEASURED ONLY ONE LEVEL OF CONTROL AND IT WAS NEAR THE TARGET. LATER THAT MORNING, THE CUSTOMER NOTICED THAT ALMOST ALL VITAMIN B12 PATIENT RESULTS WERE 100 PG/ML. AFTER THIS OBSERVATION, THE CUSTOMER RAN BOTH CONTROL LEVELS AND RESULTS WERE OUTSIDE OF RANGE. THE CUSTOMER THEN REPEATED AN UNSPECIFIED NUMBER OF PATIENT SAMPLES ON A SECOND ANALYZER AND THE RESULTS WERE SIGNIFICANTLY DIFFERENT. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT VITAMIN B12 RESULTS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A VITAMIN B12 RESULT OF 100 PG/ML AND REPEATED AS 196 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605682 ↗