Access Vitamin B12 33000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 15099590224301), received between Feb 7, 2017 and Apr 13, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (9 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 27, 2025Class IICompleted

   Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.

   Z-2115-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026High Test Results

  ON (B)(60 2026 THE CUSTOMER REPORTED REPEATABLE FALSE ELEVATED (WITHIN NORMAL RANGE) VITAMIN B12 (ACCESS VITAMIN B12 COBALAMIN ¿ PART NUMBER 33000) RESULTS FOR ONE PATIENT ON THEIR DXI 9000 ANALYZERS SERIAL NUMBER (B)(6). THE PATIENT WAS INITIALLY INVESTIGATED AS PROBABLE MYELODYSPLASIA, AS PATIENT PRESENTED WITH MACROCYTIC ANEMIA AND NORMAL ACCESS VITAMIN B12, FOLATE, THYROID FUNCTION AND LIVER FUNCTION. ACCESS VITAMIN B12 WAS REPEATEDLY MEASURED, AND IT WAS CONSISTENTLY IN THE NORMAL REFERENCE RANGE (SEE BELOW). ON (B)(6) 2025, THE PATIENT UNDERWENT A BONE MARROW BIOPSY WHICH SHOWED SOME DYSPLASIA BUT DID NOT HAVE ANY TYPICAL FEATURES OF MYELODYSPLASTIC SYNDROME. THE UNNECESSARY BONE MARROW BIOPSY HAS BEEN ADDRESSED IN A PREVIOUS MEDWATCH REPORT (B)(4). ON (B)(6) 2025, FURTHER INVESTIGATION LED TO FIND HIGH TITERS OF INTRINSIC FACTOR ACTIVITY AND PARIETAL CELL ANTIBODIES AND VITAMIN B12 DEFICIENCY. THE PATIENT HAD REPLACEMENT THERAPY ON (B)(6) 2025. THIS MEDWATCH REPORT WILL ADDRESS THE DELAY IN PATIENT TREATMENT. THERE WERE NO HARDWARE ERRORS OR OTHER FLAGS REPORTED AT THE TIME OF THE EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS AUTOMATIC SYSTEM DIAGNOSTICS, CALIBRATION AND QUAL

  Patient problems: Insufficient Information

  MAUDE report 24854896 ↗
• InjuryApr 13, 2026High Test Results

  ON (B)(6) 2026 THE CUSTOMER REPORTED REPEATABLE FALSE ELEVATED (WITHIN NORMAL RANGE) VITAMIN B12 (ACCESS VITAMIN B12 COBALAMIN ¿ PART NUMBER 33000) RESULTS FOR ONE PATIENT ON THEIR DXI 9000 ANALYZERS SERIAL NUMBER (B)(6). THE PATIENT WAS INITIALLY INVESTIGATED AS PROBABLE MYELODYSPLASIA, AS PATIENT PRESENTED WITH MACROCYTIC ANEMIA AND NORMAL ACCESS VITAMIN B12, FOLATE, THYROID FUNCTION AND LIVER FUNCTION. ACCESS VITAMIN B12 WAS REPEATEDLY MEASURED, AND IT WAS CONSISTENTLY IN THE NORMAL REFERENCE RANGE (SEE BELOW). ON (B)(6) 2025, THE PATIENT UNDERWENT A BONE MARROW BIOPSY WHICH SHOWED SOME DYSPLASIA BUT DID NOT HAVE ANY TYPICAL FEATURES OF MYELODYSPLASTIC SYNDROME. THIS MEDWATCH REPORT ADDRESSES THE UNNECESSARY BONE MARROW BIOPSY. ON (B)(6) 2025, FURTHER INVESTIGATION LED TO FIND HIGH TITERS OF INTRINSIC FACTOR ACTIVITY AND PARIETAL CELL ANTIBODIES AND VITAMIN B12 DEFICIENCY. THE PATIENT HAD REPLACEMENT THERAPY ON (B)(6) 2025. A SECOND MEDWATCH REPORT WILL ADDRESS THE DELAY IN PATIENT TREATMENT (B)(4). THERE WERE NO HARDWARE ERRORS OR OTHER FLAGS REPORTED AT THE TIME OF THE EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS AUTOMATIC SYSTEM DIAGNOSTICS, CALIBRATION AND QUALITY CONTROL WE

  Patient problems: Insufficient Information

  MAUDE report 24854497 ↗
• InjuryApr 2, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2025 THE CUSTOMER REPORTED IMPRECISE VITAMIN B12 RESULTS WERE GENERATED FOR AROUND TEN PATIENTS ON THE CUSTOMER'S DXI 9000 ANALYZERS (PART NUMBER C11137 AND SERIAL NUMBER (SN) (B)(6). THE CUSTOMER REPORTED THAT ONE PATIENT HAD A PLANNED GASTROSCOPY THAT WAS DELAYED BY ONE DAY BASED UPON THE IMPRECISE ACCESS RESULTS. IT IS UNKNOWN IF A TREATMENT WAS ALSO DELAYED. NO FURTHER INFORMATION WAS PROVIDED. THE INITIAL VITAMIN B12 RESULT FOR THIS PATIENT WAS 0 PG/ML (9:52) ON (B)(6) 2025. THIS SAMPLE WAS REPEATED TWICE. FIRST REPEAT TEST GAVE "NO RESULT" WITH IND FLAGGED (10:50) MEANING THAT RELATIVE LIGHT UNITS (RLU) WERE ABOVE THE CALIBRATOR S0 SUGGESTING A LOW DOSE (COMPETITIVE ASSAY). THE SECOND RESULT WAS GREATER THAN 1,537 PG/ML (11:58), OVR (OVER-RANGED) FLAGGED. THEN THE CUSTOMER REPEATED THE SAMPLE WITH THE ON-BOARD DILUTION AND THE DILUTION RESULT WAS LOWER THAN 1,275 PG/ML (13:50). NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS INCIDENT. CALIBRATION CAL-1 PASSED ON 12MAR2025 WITH REAGENT LOT 472294 AND CALIBRATOR LOT 439769. CALIBRATION CAL-2 PASSED ON 20MAR2025 AT 12:36 PM WITH REAGENT LOT 472294 AND CALIBRATOR LOT 439769. QUALITY

  Patient problems: Insufficient Information

  MAUDE report 21752125 ↗
• InjuryJan 29, 2025Low Test Results; Low Test Results

  ON 03JAN2025 THE CUSTOMER REPORTED FALSE LOW VITAMIN B12 PATIENT RESULTS (ACCESS VITAMIN B12, PART NUMBER 33000 AND LOT NUMBER 439850) WERE GENERATED ON THE CUSTOMER'S DXI ANALYZERS (DXI 800 ACCESS IMMASSY W/SPOT B, PART NUMBER A71456 AND SERIAL NUMBERS (SN) (B)(6)). THE CUSTOMER REPORTED THAT TWO PATIENTS HAD A CHANGE IN TREATMENT BASED ON THE FALSE LOW ACCESS VITAMIN B12 RESULTS. THIS REPORT WILL ADDRESS THE PATIENT WHO STARTED ORAL VITAMIN B12 SUPPLEMENTATION BASED ON THE LOW VITAMIN B12 RESULT OBTAINED ON (B)(6) 2024. THE INITIAL VITAMIN B12 RESULT WAS 85.1 PMOL/L ON DXI SN (B)(6) ON (B)(6) 2024, REPEATED AT 119.7 PMOL/L. PATIENT RESULT WAS AMENDED. THE CUSTOMER'S VITAMIN B12 REFERENCE RANGE WAS 115-1000 PMOL/L. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS INCIDENT. SYSTEM CHECK DATA WAS NOT PROVIDED. CALIBRATIONS PASSED WITH REAGENT LOT 439850 ON BOTH INSTRUMENTS. THE FIELD APPLICATION SPECIALIST (FAS) ANALYZED QUALITY CONTROL (QC) DATA AND FOUND THAT THE 3 LEVELS OF QC RAN ON BOTH DXI INSTRUMENTS WERE ERRATIC WITH HIGH %CV AND OUTSIDE HIGH OR LOW SD VALUES. THE CUSTOMER STATED SOME HIGH VITB12 QC RESULTS WERE >1134 WITH ¿NO VALUE¿. MOS

  Patient problems: Insufficient Information

  MAUDE report 21264257 ↗
• InjuryJan 27, 2025Low Test Results; Low Test Results

  ON 03JAN2025 THE CUSTOMER REPORTED FALSE LOW VITAMIN B12 PATIENT RESULTS (ACCESS VITAMIN B12, PART NUMBER 33000 AND LOT NUMBER 439850) WERE GENERATED ON THE CUSTOMER'S DXI ANALYZERS (DXI 800 ACCESS IMMASSY W/SPOT B, PART NUMBER A71456 AND SERIAL NUMBERS (SN) (B)(6). THE CUSTOMER REPORTED THAT TWO PATIENTS HAD A CHANGE IN TREATMENT BASED ON THE FALSE LOW ACCESS VITAMIN B12 RESULTS. THIS REPORT WILL ADDRESS ONE OF THE TWO PATIENTS WITH A CHANGE IN TREATMENT. THIS PATIENT WAS PRESCRIBED VITAMIN B12 INJECTIONS BASED ON THE FALSE LOW ACCESS VITAMIN B12 RESULT OBTAINED ON (B)(6) 2024. HOWEVER, IT IS UNKNOWN IF SOME INJECTION WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. THE INITIAL VITAMIN B12 PATIENT RESULT WAS 66.4 PMOL/L ON DXI SN (B)(6) ON (B)(6) 2024, REPEATED AT >1106.7 PMOL/L. PATIENT RESULT WAS AMENDED. THE CUSTOMER'S VITAMIN B12 REFERENCE RANGE WAS 115-1000 PMOL/L. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS INCIDENT. SYSTEM CHECK DATA WAS NOT PROVIDED. CALIBRATIONS PASSED WITH REAGENT LOT 439850 ON BOTH INSTRUMENTS. THE FIELD APPLICATION SPECIALIST (FAS) ANALYZED QUALITY CONTROL (QC) DATA AND FOUND THAT THE 3 LEVELS OF QC RAN ON B

  Patient problems: Insufficient Information

  MAUDE report 21240292 ↗
• InjuryMar 30, 2023Low Test Results; Low Test Results

  ON 26MAR2023 THE CUSTOMER REPORTED OBTAINING ERRONEOUS LOW B12 (ACCESS B12, PART NUMBER 33000 AND LOT NUMBER 272194) RESULT OF 0 PG/ML WAS OBTAINED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE CUSTOMER REPEATED THE PATIENT SAMPLE AND OBTAINED THE SAME VALUE OF 0 PG/ML. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT WAS ADMINISTERED A VITAMIN B12 SHOT (DOSE NOT PROVIDED). THE PATIENT WAS REDRAWN AND RETESTED FOR B12 THE FOLLOWING DAY AND A RESULT OF >1504 PG/ML (OVER RANGE FLAGGED) WAS OBTAINED. THERE IS NO FURTHER REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT OR PATIENT INJURY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER DOES NOT PERFORM QUALITY CONTROL (QC) TESTING; THEREFORE, THERE ARE NO QC RESULTS FOR REVIEW. SAMPLE COLLECTION AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE,

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16644196 ↗
• InjuryJun 16, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN INCREASED NUMBER OF LOW VITAMIN B12 (ACCESS VITAMIN B12, PART NUMBER 33000 AND LOT NUMBER 272031) PATIENT RESULTS WERE GENERATED FOR MONTH OF MAY2022 ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY ANALYZERS (PART NUMBER A71456 AND SERIAL NUMBERS (B)(4) AND (B)(4)). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER WASN¿T SURE HOW MANY PATIENTS BUT REPORTED THAT AT LEAST ONE PATIENT RECEIVED UNNECESSARY B12 SUPPLEMENTATION (DOSES NOT PROVIDED). THERE WAS NO FURTHER INFORMATION REGARDING CHANGE TO PATIENT TREATMENT OR MANAGEMENT OR PATIENTS OUTCOME PROVIDED. THERE WAS NO REPORT OF HARDWARE ERRORS OR OTHER ISSUES WITH THE DXI INSTRUMENTS. BOTH ANALYZERS HAVE HAD ALL MAINTENANCE COMPLETED AND PREVENTATIVE MAINTENANCE IS NOT OVERDUE. NO OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. PER CUSTOMER VERBAL REPORTS, WEEKLY SYSTEM CHECKS PASSED. CALIBRATIONS PASSED AND QUALITY CONTROL (QC) WERE WITHIN RANGES ON BOTH ANALYZERS. THE VITAMIN B12 REAGENT LOT WAS NOT CHANGED. LOW LEVEL B12 EQA SAMPLES FROM APRIL HAVE BEEN RERUN AND THE RESULTS ARE FINE AND IN KEEPING WITH THE BECKMAN GROUP. THE CUST

  Patient problems: Insufficient Information

  MAUDE report 14711061 ↗
• InjuryOct 13, 2021Low Test Results; Low Test Results

  ON (B)(6) 2021, THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW ACCESS VITAMIN B12 RESULTS SINCE MONTH OF AUGUST FOR SEVERAL PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER SERIAL NUMBER (B)(4). THE CUSTOMER STATED THE PATHOLOGIST WAS QUESTIONING THE LOW B12 RESULTS AND THEY SENT OUT THE SAMPLES TO ANOTHER LAB (QUEST) WHERE THEY HAVE BEEN TESTED ON THE SIEMENS CENTAUR METHOD. THE SIEMENS CENTAUR RESULTS WERE 100 UNITS (OR MORE) HIGHER THAN THE ACCESS VITAMIN B12 RESULTS. PER THE CUSTOMER, THE PATHOLOGIST IS CONCERNED BY THE RESULTS BELOW 200. THE CUSTOMER ONLY PROVIDED VITAMIN B12 RESULTS FOR FIVE (5) PATIENTS: 1 PATIENT (COLLECTED ON (B)(6) 2021) WITH DXI RESULT AT 146 PG/ML OBTAINED ON CENTAUR AT 401 PG/ML. 1 PATIENT (COLLECTED ON (B)(6) 2021) WITH DXI RESULT AT 189 PG/ML OBTAINED ON CENTAUR AT 391 PG/ML. 1 PATIENT (COLLECTED ON (B)(6) 2021) WITH DXI RESULT AT 167 PG/ML AND AT 303 PG/ML ON CENTAUR. 1 PATIENT (COLLECTED ON (B)(6) 2021) WITH DXI RESULT AT 302 PG/ML AND AT 514 PG/ML ON CENTAUR. 1 PATIENT (COLLECTED ON (B)(6) 2021) WITH DXI RESULT AT 189 PG/ML AND AT 329 PG/ML ON CENTAUR. THE CUSTOMER REPORTED THAT THE DOCTOR HAS BEEN GIVEN B12 SUPPLEMENTS B

  Patient problems: Insufficient Information

  MAUDE report 12622657 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 09JULY2021 THE CUSTOMER REPORTED THAT ON (B)(6) 2021, ERRONEOUS LOW B12 RESULTS (ACCESS VITAMIN B12, PART NUMBER 33000 AND LOT NUMBER 971292) WERE GENERATED ON THE CUSTOMER'S DXI 800 (DXI 800 ACCESS IMMUNOASSAY ANALYZER W/ SPOT B, PART NUMBER A71456 AND SERIAL NUMBER (B)(4)) FOR AN UNKNOWN NUMBER OF PATIENTS. THE INITIAL LOW RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER REPORTED A CHANGE TO PATIENT TREATMENT FOR SEVERAL PATIENTS; THE PATIENTS WERE PRESCRIBED VITAMIN B 12 SUPPLEMENTS (DOSAGES NOT PROVIDED). THE CUSTOMER REPORTED THE LOW RESULTS WERE DISCORDANT WITH PATIENTS¿ CLINICAL FILES. CUSTOMER ALSO REPORTED HIGHER B12 RESULTS WERE OBTAINED UPON REPEAT FOR SOME PATIENT SAMPLES (NO DATA PROVIDED). SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATIONS AND QUALITY CONTROL (QC) HAVE BEEN PASSING WITHIN SPECIFICATIONS AS REPORTED BY THE CUSTOMER. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION AND HANDLING INFORMATION SUCH AS SAMPLE TYPE, VOLUME DRAWN, TRANSPORTATION AND HANDLING, CENTRIFUGATION, STORAGE OR OTHER SAMPLE HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 12263739 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THE CUSTOMER REPORTED THAT ON (B)(6) 2021, ERRONEOUS LOW B12 RESULTS (ACCESS VITAMIN B12, PART NUMBER 33000 AND LOT NUMBER 172011) WERE GENERATED ON THE CUSTOMER'S DXI 800 (DXI 800 ACCESS IMMUNOASSAY ANALYZER W/ SPOT B, PART NUMBER A71456 AND SERIAL NUMBER (B)(4)) FOR AN UNKNOWN NUMBER OF PATIENTS. THE INITIAL LOW RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER REPORTED A CHANGE TO PATIENT TREATMENT FOR SEVERAL PATIENTS; THE PATIENTS WERE PRESCRIBED VITAMIN B 12 SUPPLEMENTS (DOSAGES NOT PROVIDED). THE CUSTOMER REPORTED THE LOW RESULTS WERE DISCORDANT WITH PATIENTS¿ CLINICAL FILES. CUSTOMER ALSO REPORTED HIGHER B12 RESULTS WERE OBTAINED UPON REPEAT FOR SOME PATIENT SAMPLES (NO DATA PROVIDED). SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATIONS AND QUALITY CONTROL (QC) HAVE BEEN PASSING WITHIN SPECIFICATIONS AS REPORTED BY THE CUSTOMER. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION AND HANDLING INFORMATION SUCH AS SAMPLE TYPE, VOLUME DRAWN, TRANSPORTATION AND HANDLING, CENTRIFUGATION, STORAGE OR OTHER SAMPLE HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 12263693 ↗
• InjuryMar 26, 2021Low Test Results; Low Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED LOW VITAMIN B12 (ACCESS VITAMIN B12 COBALAMIN ¿ PART NUMBER 33000) PATIENT RESULTS IN COMPARISON WITH OTHER METHODS, OBTAINED ON DXI 800 ACCESS IMMUNO ASSAY W/SPOT B ANALYZERS. THE CUSTOMER USES NORMAL REFERENCE RANGES STATED IN THE VITAMINB12 INSTRUCTIONS FOR USE (IFU): 133 - 675 PMOL/L (180 - 914 PG/ML). CLINICIANS USE 148 PMOL/L (200 PG/ML) AS A CUT-OFF FOR POSSIBLE VITAMIN B12 DEFICIENCY REQUIRING FURTHER INVESTIGATION INSTEAD OF A REFERENCE INTERVAL. THE CUSTOMER REPORTED THAT AFTER THE INTRODUCTION OF THE ACCESS VITAMIN B12 ASSAY ON (B)(6) 2020, APPROXIMATELY 22% OF VITAMIN B12 RESULTS REPORTED HAVE BEEN < 150 PMOL/L. IN COMPARISON, USING THE ROCHE METHOD (PREVIOUS METHOD), ONLY 3.5% WERE BELOW THIS CUT-OFF. THE CUSTOMER REPORTED A CLINICAL PROBLEM BECAUSE THE DOCTORS ARE FINDING IT HARD TO UNDERSTAND THESE RESULTS AND TREAT PATIENTS CORRECTLY BASED ON THEM. THE CUSTOMER SUGGESTED THAT UNNECESSARY PRESCRIPTIONS WERE MADE AND THAT VITAMIN B12 PRESCRIPTIONS DOUBLED AFTER THE INTRODUCTION OF THE ACCESS ASSAY ((B)(6) 2020). NO DETAIL REGARDING THE TYPE OF PRESCRIPTION WAS PROVIDED (OVER THE COUNTER B12 OR INJECTIONS). NO FURTHER CHANGE IN TREA

  Patient problems: Insufficient Information

  MAUDE report 11573725 ↗
• InjuryOct 15, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUS LOW VITAMIN B12 (ACCESS VITAMIN B12, PART NUMBER (B)(4) AND LOT NUMBER 921766) RESULTS WERE GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY ANALYZERS (DXI) (PART NUMBER (B)(4) AND SERIAL NUMBERS (B)(4) AND (B)(4). THE CUSTOMER REPORTED ADDITIONAL ERRONEOUS LOW VITAMIN B12 RESULTS WERE ALSO GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY ANALYZERS AT AN ALTERNATE SITE (DXI PART NUMBERS AND SERIAL NUMBERS NOT PROVIDED). THE INITIAL RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. ON (B)(6) 2020 THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF PATIENTS RECEIVED VITAMIN B12 INJECTIONS (DOSES NOT PROVIDED). THERE WAS NO FURTHER INFORMATION REGARDING CHANGE TO PATIENT TREATMENT OR MANAGEMENT OR PATIENT OUTCOME PROVIDED. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECKS AND CALIBRATIONS WERE NOT PROVIDED FOR REVIEW. THERE WAS NO REPORT OF HARDWARE ERRORS OR OTHER ISSUES WITH THE DXI INSTRUMENTS. NO OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. QUALITY CONTROL INFORMATION PROVIDED DEMONSTRATED A SHIFT LOWER IN THE CUSTOMER' QUALITY CONTROL L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10683918 ↗
• MalfunctionNov 15, 2019Non Reproducible Results; Non Reproducible Results

  ON 01NOV2019 THE CUSTOMER REPORTED THAT ON (B)(6) 2019, NON-REPRODUCIBLE ERRATIC VITAMIN B12 (ACCESS VITAMIN B12) RESULTS HAD BEEN GENERATED ON THE CUSTOMER'S UNICEL DXI800 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4) FOR ONE PATIENT SAMPLE. AN INITIAL SAMPLE RESULT OF 88.5 PMOL/L WAS OBTAINED ON (B)(6) 2019 AT 1436; THE SAMPLE WAS REPEAT TESTED AND A RESULT OF 266.4 PMOL/L WAS OBTAINED AT 1520. THE SAMPLE WAS REPEAT TESTED TWO MORE TIMES AND RESULT OF 53.0 PMOL/L AND 53.1 PMOL/L WERE OBTAINED AT 1825 AND 1826, RESPECTIVELY. THE SAMPLE WAS ALSO TESTED ONE TIME ON THE CUSTOMER'S ALTERNATE UNICEL DXI800 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4) ON (B)(6) 2019 AT 1726 AND A RESULT OF 66.8 PMOL/L WAS OBTAINED. THE CUSTOMER DID NOT INDICATE WHETHER ANY OF THESE RESULTS WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO PATIENT CARE OR TREATMENT. SYSTEM CHECK AND CALIBRATION WERE PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. QUALITY CONTROL INFORMATION WAS REQUESTED BUT NOT PROVIDED FOR REVIEW. INFORMATION REGARDING PATIENT SAMPLE COLLECTION AND PROCESSING WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9329281 ↗
• MalfunctionFeb 12, 2019High Test Results; High Test Results

  ON (B)(6) 2019 THE CUSTOMER REPORTED THAT NON-REPRODUCIBLE ELEVATED VITAMIN B12 (ACCESS VITAMIN B12) RESULTS HAD BEEN GENERATED ON THE CUSTOMER'S UNICEL DXI800 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE PATIENT SAMPLE. THE INITIAL ELEVATED VITAMIN B12 RESULT WAS 219.23 PMOL/L WAS RELEASED FROM THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND REPEATED WITH AN ALTERNATE METHOD (NOT PROVIDED); RESULT PROVIDED WAS <111 PMOL/L. THERE WAS NO REPORT OF CHANGE TO PATIENT CARE OR TREATMENT. CALIBRATION, QUALITY CONTROL AND SYSTEM CHECK WERE ALL PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE INCIDENT. INFORMATION REGARDING PATIENT SAMPLE COLLECTION AND PROCESSING WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331842 ↗
• InjuryOct 19, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE VITAMIN B12 (ACCESS VITAMIN B12) PATIENT RESULTS ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (S/N: (B)(4)). THE CUSTOMERS PATIENT RESULTS WERE LOWER THAN THE NORMAL RANGE OF THE ASSAY. TEN PATIENT SAMPLES WERE SENT TO AN ALTERNATE FACILITY FOR TESTING AND NINE OF THE SAMPLES RECOVERED WITHIN THE NORMAL RANGE OF THE ASSAY. ONE PATIENT SAMPLE WAS REPRODUCIBLE AND RECOVERED LOW ON REPEAT. THERE WAS A CHANGE IN PATIENT TREATMENT. AN UNKNOWN NUMBER OF PATIENTS WERE ADMINISTERED VITAMIN B12 INJECTIONS BASED ON THE FALSE LOW VITAMIN B12 RESULTS. QUALITY CONTROLS (QC) RECOVERED INTERMITTENTLY IN AND OUT OF SPECIFICATIONS. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Code Available

  MAUDE report 7984456 ↗
• InjuryFeb 7, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE, NORMAL VITAMIN B12 (ACCESS B12) RESULTS FOR ONE (1) PATIENT SINCE (B)(6) 2016 ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). ON (B)(6) 2016 THE CUSTOMER OBTAINED AN ACCESS B12 RESULT WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY FOR THE PATIENT. THIS SAMPLE WAS THEN SENT TO A REFERENCE LABORATORY AND TESTED ON AN ALTERNATE METHODOLOGY (ROCHE ELECSYS) WHICH PRODUCED A DISCORDANT RESULT BELOW THE NORMAL REFERENCE RANGE OF THE ASSAY. THE NORMAL ACCESS B12 RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS A CHANGE IN PATIENT MANAGEMENT IN CONJUNCTION WITH THE NORMAL ACCESS B12 RESULTS AS THE PATIENT'S VITAMIN B12 TREATMENTS WERE DELAYED UNTIL AFTER RECEIVING THE ROCHE RESULT IN (B)(6) OF 2016. SYSTEM VERIFICATION PARAMETERS SUCH AS QC (QUALITY CONTROLS), CALIBRATIONS AND SYSTEM CHECKS WERE PERFORMING WITHIN ASSAY AND LABORATORY SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WERE NO REPORTS OF ISSUES WITH OTHER ANALYTES, SAMPLES OR THE HARDWARE IN CONJUNCTION WITH THIS EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN A 5 ML (MILLILITER) SERUM TUBE WITH A GEL SEPARATOR WHICH WAS CENTRIFUGED FOR TEN (10) MIN

  Patient problems: No Code Available

  MAUDE report 6307348 ↗