Access SARS-CoV-2 IgG C58961Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 15099590738648), received between Aug 13, 2020 and Mar 3, 2022 — classified as 57 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (50 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022 THE CUSTOMER REPORTED THAT ON (B)(6) 2022, A NON-REACTIVE COVID IGG (ACCESS SARS-COV-2-IGG, PART NUMBER C58961 AND LOT NUMBER 125390) RESULT WAS GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE NON-REACTIVE PATIENT RESULTS WERE DISCORDANT TO RESULTS GENERATED USING THE DIASORIN SARS-COV-2 TRIMERIC S IGG SEMI-QUANTITATIVE RESULT. THERE WAS NO REPORT OF CHANGE TO PATIENT CARE OR TREATMENT IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 13660309 ↗
• MalfunctionMar 3, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022 THE CUSTOMER REPORTED THAT ON (B)(6) 2022 AND (B)(6) 2022, NON-REACTIVE COVID IGG (ACCESS SARS-COV-2-IGG, PART NUMBER C58961 AND LOT NUMBER 125390) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE NON-REACTIVE PATIENT RESULTS WERE DISCORDANT TO RESULTS GENERATED USING THE DIASORIN SARS-COV-2 TRIMERIC S IGG SEMI-QUANTITATIVE RESULT. THERE WAS NO REPORT OF CHANGE TO PATIENT CARE OR TREATMENT IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 13660304 ↗
• MalfunctionMar 3, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022 THE CUSTOMER REPORTED THAT ON (B)(6) 2021, NON-REACTIVE COVID IGG (ACCESS SARS-COV-2-IGG, PART NUMBER C58961 AND LOT NUMBER 125390) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE NON-REACTIVE PATIENT RESULTS WERE DISCORDANT TO RESULTS GENERATED USING THE DIASORIN SARS-COV-2 TRIMERIC S IGG SEMI-QUANTITATIVE RESULT. THERE WAS NO REPORT OF CHANGE TO PATIENT CARE OR TREATMENT IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 13660288 ↗
• MalfunctionJan 25, 2022False Negative Result; False Negative Result

  ON (B)(6) 20211 THE CUSTOMER REPORTED REPEATABLE NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 172108) AND SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER NOT PROVIDED) RESULTS WERE GENERATED FOR ONE PATIENT ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER 606202). THE CUSTOMER REPORTED REACTIVE RESULTS USING VITROS 5600 COV2G ASSAY. THIS REPORT ADDRESS THE REPEATABLE NON-REACTIVE SARS-COV-2 IGG RESULTS. A SECOND REPORT WILL ADDRESS THE NON-REACTIVE ACCESS SARS-COV-2 IGG II RESULTS. ON (B)(6) 2021, THE ACCESS SARS-COV-2 IGG RESULTS WERE 0.66 S/CO (NON-REACTIVE: <1.0 S/CO), REPEATED AT 0.75 S/CO THE DAY AFTER. THE ACCESS SARS-COV-2 IGG II RESULT WAS ALSO NON-REACTIVE AT 6.47 AU/ML (NON REACTIVE: < 10 AU/ML) ON (B)(6) 2021. A SECOND SAMPLE FROM THE SAME PATIENT GAVE SIMILAR RESULTS. ON (B)(6) 2021 THE ACCESS SARS-COV-2 IGG RESULTS WERE 0.67 S/CO, REPEATED AT 0.66 S/CO THE DAY AFTER. THE ACCESS SARS-COV-2 IGG II RESULT WAS ALSO NON-REACTIVE AT 6.44 AU/ML ON (B)(6) 2021. ON 30DEC2021, BOTH SAMPLES WERE TESTED USING VITROS 5600 COV2G ASSAY WITH DISCORDANT REACTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343032 ↗
• MalfunctionDec 16, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED A NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961) RESULT WAS GENERATED ON THE CUSTOMER'S DXI 600 ACCESS IMMUNOASSAY W/DUAL GANTRY ANALYZER (PART NUMBER A71461 AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED QUESTIONED A SARS COV2 RESULT OF 0 S/CO (NON-REACTIVE) WAS GENERATED FOR ONE PATIENT. THE CUSTOMER NOTED IT HAPPENED A COUPLE MONTHS AGO. HOWEVER NO DATA AND NO SPECIFIC DATE OF EVENT WERE PROVIDED BY THE CUSTOMER. THE RESULT WAS QUESTIONED AS THE PATIENT HAD RECENTLY HAD A COVID-19 BOOSTER VACCINATION. THE CUSTOMER REPORTED THE PATIENT WAS TESTED AT AN ALTERNATE SITE AND METHODOLOGY (DIASORIN LIASON) AND A HIGHER DISCORDANT RESULT OF 347 AU/ML (REACTIVE>13) WAS OBTAINED. NO INFORMATION ABOUT PATIENT CLINICAL FILE WAS PROVIDED (PCR RESULTS OR SYMPTOM INFORMATION ARE UNKNOWN). NO FURTHER INFORMATION WAS PROVIDED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. ALL RECENT SYSTEM CHECKS AND CALIBRATIONS PASSED WITHIN SPECIFICATIONS. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017852 ↗
• MalfunctionAug 24, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NEGATIVE (NON-REACTIVE) COVID IGG RESULTS (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 172051) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 386220 AND SERIAL NUMBER (B)(4)) FOR THREE PATIENTS. TWO OF THE PATIENTS WERE TESTED AT AN ALTERNATE LABORATORY USING A QUANTITATIVE ASSAY AND POSITIVE RESULTS WERE OBTAINED. THE CUSTOMER REPORTED THE RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER'S MOST RECENT COVID IGG CALIBRATION HAD PASSED (ALTHOUGH CALIBRATION WAS EXPIRED AT THE TIME OF THE EVENT). THE CUSTOMER REPORTED THERE WAS NO QUALITY CONTROL TESTING PERFORMED. NO SYSTEM CHECK WAS AVAILABLE FOR REVIEW. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 12359357 ↗
• MalfunctionAug 10, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NEGATIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 124130) WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS ANALYZER, PART NUMBER A71457 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE CUSTOMER REPORTED THE RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER REPORTED THERE WAS NO CHANGE TO PATIENT TREATMENT IN CONJUNCTION WITH THE EVENT. THE CUSTOMER REPORTED THE PATIENT SAMPLE HAD GENERATED NONREACTIVE RESULTS WITH A DIFFERENT METHODOLOGY (ABBOTT SARS COV 2 IGG) BUT GENERATED POSITIVE RESULTS WITH A SARS-COV-2 TOTAL AB, S PROTEIN ASSAY (MANUFACTURER UNKNOWN). THE CUSTOMER ALSO REPORTED THE PATIENT HAD PREVIOUSLY BEEN VACCINATED WITH THE JOHNSON AND JOHNSON SARS-COV-2 VACCINE, ADMINISTERED ON (B)(6) 2021. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299891 ↗
• MalfunctionAug 10, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NEGATIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 124130) WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS ANALYZER, PART NUMBER A71457 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE CUSTOMER REPORTED THE RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER REPORTED THERE WAS NO CHANGE TO PATIENT TREATMENT IN CONJUNCTION WITH THE EVENT. THE CUSTOMER REPORTED THE PATIENT SAMPLE HAD GENERATED NONREACTIVE RESULTS WITH A DIFFERENT METHODOLOGY (ABBOTT SARS COV 2 IGG) BUT GENERATED POSITIVE RESULTS WITH A SARS-COV-2 TOTAL AB, S PROTEIN ASSAY (MANUFACTURER UNKNOWN). THE CUSTOMER ALSO REPORTED THE PATIENT HAD PREVIOUSLY BEEN VACCINATED WITH THE MODERNA SARS-COV-2 VACCINE, WITH THE SECOND DOSE ADMINISTERED ON (B)(6) 2021. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299889 ↗
• MalfunctionJul 12, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED ONE NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 172017) RESULT WAS GENERATED FOR ONE VACCINATED PATIENT ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE PATIENT RESULT FOR THE SARS-COV-2 IGG ASSAY WAS NON-REACTIVE AT 0.73 S/CO ON (B)(6) 2021. ON (B)(6) 2021, THE COVIPROTECT SARS COV2 SPIKE ANTIBODY QUANTITATIVE RESULT WAS POSITIVE AT 68 BAU/ML (BIOLOGICAL REFERENCE INTERVAL: POSITIVE = 7.1). THIS TEST DETECTS AND ESTIMATES THE AMOUNT OF NEUTRALIZING ANTIBODIES. NO VACCINE'S NAME AND NO VACCINATION DATES WERE PROVIDED. NO PCR TEST PROVIDED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. ARCDATA ANALYSIS PROVIDED WAS UNREMARKABLE AND DID NOT HIGHLIGHT A PERFORMANCE ISSUE. THE PATIENT RESULT WAS CEX FLAGGED. CALIBRATION PASSED ON 03APR2021 WITH REAGENT LOT 172017 AND CALIBRATOR LOT 922849. SYSTEM CHECK PASSED ON 26MAY2021. QC WAS PASSIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148848 ↗
• MalfunctionJul 7, 2021False Negative Result; False Negative Result

  ON 21JUN2021 THE CUSTOMER REPORTED NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 922776) RESULTS FOR FIVE PATIENTS WERE GENERATED ON THE CUSTOMER'S REMANUFACTURED DXI IMMUNOASSAY ANALYZER (PART NUMBER A25288 AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS IN AN ALTERNATE LABORATORY (NO FURTHER INFORMATION WAS PROVIDED REGARDING THE METHODOLOGY USED AT ALTERNATE SITE). PER CUSTOMER VERBAL'S REPORT, PATIENTS 2-5 FROM THE DATA TABLE BELOW (REFER TO THE "RELEVANT TESTS/LABORATORY DATA" ) HAD A HISTORY OF COVID INFECTION. NONE OF THE PATIENTS WERE REPORTED TO BE VACCINATED AGAINST COVID-19. NO HISTORICAL CLINICAL INFORMATION WAS AVAILABLE FOR PATIENT 1. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. COV2G CALIBRATION PASSED ON 07JUN2021 USING REAGENT LOT 922776 AND CALIBRATOR LOT 922849. QC WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. THE LOCAL SUPPORT ORGANIZATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129177 ↗
• MalfunctionJul 7, 2021False Negative Result; False Negative Result

  ON 21JUN2021 THE CUSTOMER REPORTED NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 922776) RESULTS FOR FIVE PATIENTS WERE GENERATED ON THE CUSTOMER'S REMANUFACTURED DXI IMMUNOASSAY ANALYZER (PART NUMBER A25288 AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS IN AN ALTERNATE LABORATORY (NO FURTHER INFORMATION WAS PROVIDED REGARDING THE METHODOLOGY USED AT ALTERNATE SITE). PER CUSTOMER VERBAL'S REPORT, PATIENTS 2-5 FROM THE DATA TABLE BELOW (REFER TO THE "RELEVANT TESTS/LABORATORY DATA" ) HAD A HISTORY OF COVID INFECTION. NONE OF THE PATIENTS WERE REPORTED TO BE VACCINATED AGAINST COVID-19. NO HISTORICAL CLINICAL INFORMATION WAS AVAILABLE FOR PATIENT 1. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. COV2G CALIBRATION PASSED ON 07JUN2021 USING REAGENT LOT 922776 AND CALIBRATOR LOT 922849. QC WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. THE LOCAL SUPPORT ORGANIZATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129173 ↗
• MalfunctionJul 2, 2021False Negative Result; False Negative Result

  ON 14JUNE2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 922776) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR THREE PATIENT SAMPLES. THE CUSTOMER DID NOT PROVIDE DATES OF TESTING. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT CARE OF TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT'S SAMPLES HAD GENERATED REACTIVE RESULTS WITH OTHER METHODOLOGIES. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CALIBRATION WAS NOTED TO HAVE BEEN GENERATED USING EXPIRED CALIBRATOR MATERIAL. THE CUSTOMER WAS NOT RUNNING QUALITY CONTROL (QC) SAMPLES AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE

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

  MAUDE report 12109282 ↗
• MalfunctionJun 8, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 971198) RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS IN AN ALTERNATE LABORATORY (NO FURTHER INFORMATION WAS PROVIDED). ADDITIONAL INFORMATION REGARDING THE IMPACTED SAMPLES WAS NOT PROVIDED IN THIS EVENT. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. THE EXPIRATION DATE OF THE REAGENT LOT PROVIDED BY CUSTOMER IS 23JAN2021. LOCAL SUPPORT DISCUSSED DIFFERENCES IN METHODS WITH THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956468 ↗
• MalfunctionMay 31, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 172017) RESULTS FOR THREE PATIENTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). ON (B)(6) 2021, THE RESULTS (PATIENT ONE: 0.22 S/CO, PATIENT TWO: 0.49 S/CO AND PATIENT THREE: 0.69 S/CO) WERE QUESTIONED AS THEY DID NOT CORRELATE WITH AN ALTERNATE METHODOLOGY (ROCHE ELECSYS ANTI-SARS-COV-2 S SEMIQUANTITATIVE TOTAL ANTIBODY, DATA NOT PROVIDED) AND ALL THREE SAMPLES WERE FROM VACCINATED PATIENTS. THE PATIENTS HAD RECEIVED COVAXIN VACCINE, WITH THE 2ND DOSE ADMINISTERED ON THE FIRST WEEK OF (B)(6) 2021. NO PCR (POLYMERASE CHAIN REACTION) TESTING HAD BEEN PERFORMED ON THE PATIENTS. NO SYMPTOMS OF COVID-19 HAD BEEN REPORTED. NONE OF THE PATIENTS HAD BEEN HOSPITALIZED WITH COVID-19 IN CONNECTION WITH THE EVENT. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. COV2G CALIBRATION PASSED ON (B)(6) 2021 USING REAG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907667 ↗
• MalfunctionApr 26, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 922628) WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021 FOR ONE PATIENT SAMPLE. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT CARE OF TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT SAMPLE HAD GENERATED REACTIVE RESULTS WITH THE ROCHE ELECSYS ANTI-SARS-COV-2 S ASSAY. THE CUSTOMER REPORTED THAT THE PATIENT WAS LABORATORY TECHNICIANS HAD RECEIVED THE FIRST OF TWO DOSES OF THE ASTRA-ZENECA VACCINE 55 DAYS PRIOR TO TESTING. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INF

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

  MAUDE report 11724608 ↗
• MalfunctionApr 26, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 922628) WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021 FOR TWO PATIENT SAMPLES. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT CARE OF TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT SAMPLE HAD GENERATED REACTIVE RESULTS WITH THE ROCHE ELECSYS ANTI-SARS-COV-2 S ASSAY. THE CUSTOMER REPORTED THAT BOTH PATIENTS WERE LABORATORY TECHNICIANS HAD RECEIVED THE FIRST OF TWO DOSES OF THE ASTRA-ZENECA VACCINE 55 DAYS PRIOR TO TESTING. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER

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

  MAUDE report 11724607 ↗
• MalfunctionApr 26, 2021False Positive Result; False Positive Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED ERRONEOUSLY REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 922628) RESULTS WERE GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT ERRONEOUS REACTIVE RESULTS WERE REPORTED AS THE CUSTOMER WAS CONFUSED WITH THE GRAY ZONE STATED IN THE INSTRUCTIONS FOR USE. THE CUSTOMER IS REPORTING RESULTS <0.8 S/CO AS NON-REACTIVE AND RESULTS = 0.8 S/CO AS REACTIVE. ONE EXAMPLE WAS PROVIDED WHERE A RESULT OF 0.85 S/CO WAS INITIALLY REPORTED AS REACTIVE. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. NO SYSTEM CHECK, QUALITY CONTROL (QC) OR CALIBRATION DATA WAS PROVIDED. PERFORMANCES OF THE ASSAY OR INSTRUMENT ARE NOT QUESTIONED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED, THE STATUS AND GRY FLAG WERE CORRECTLY GENERATED BY THE DXI 800 INSTRUMENT AND CORRECTLY TRANSFERRED TO THE LIS. PER CUSTOMER¿S REPORT, IT ONLY REPORTS NON-REACTIVE OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723524 ↗
• MalfunctionApr 7, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NEGATIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 922776) WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) FOR AN TWO SAMPLES FROM ONE PATIENT. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT CARE OF TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT SAMPLE HAD GENERATED REACTIVE RESULTS WITH TWO DIFFERENT SARS-COV-2 ASSAYS: THE ROCHE SARS-COV-2 AB ASSAY AND THE ABBOTT ALINITY SARS-COV-2 IGG ASSAY. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

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

  MAUDE report 11630891 ↗
• MalfunctionApr 6, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 922628) RESULTS WERE GENERATED FOR SEVERAL PATIENTS ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE NUMBER OF PATIENTS WAS NOT PROVIDED. THE CUSTOMER REPORTED THAT THE NON-REACTIVE ACCESS SARS-COV-2 IGG RESULTS WERE DISCREPANT WITH AN ALTERNATE METHODOLOGY (ROCHE COBAS'S NUCLEOCAPSIDE ASSAY). THE CUSTOMER REPORTED HAVING DONE THE TESTS ALSO ON THE INSTRUMENT UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). NO FURTHER INFORMATION WAS PROVIDED. NO CLINICAL INFORMATION WAS PROVIDED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO CALIBRATION AND NO QUALITY CONTROL (QC) WAS PROVIDED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2021. THE FSE DID NOT FIND ANY INSTRUMENT ISSUE WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619668 ↗
• MalfunctionMar 31, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 971261) RESULTS FOR TWENTY PATIENTS WERE GENERATED ON THE CUSTOMER'S UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER A30260 AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT OF 180 SAMPLES FROM PATIENTS TAKING A COVID VACCINE (NAME OF VACCINE AND DATE/TIME OF VACCINATION WERE NOT PROVIDED), 20 WERE NEGATIVE USING THE ACCESS SARS-COV-2 IGG ASSAY AND REACTIVE USING THE ROCHE ASSAY. IT WAS NOT SPECIFIED IF THE ROCHE ASSAY TARGETS ANTIBODIES ANTI-NUCLEOCAPSID (OLD ONE) OR ANTIBODIES ANTI-SPIKE PROTEIN (NEW ONE). NO PATIENT DATA WAS PROVIDED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE IF THE RESULT WAS RELEASED OUTSIDE THE LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON 27FEB20212021. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED ON 17MAR2021. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON CUSTOMER'S SITE ON (B)(6) 2021 AND COULD NOT FIND ANY ISSUE WITH TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595374 ↗
• MalfunctionMar 25, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED ONE ERRONEOUSLY NEGATIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 971261) RESULT WAS GENERATED FOR ONE PATIENT ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). ON (B)(6) 2021, ONE NON-REACTIVE ACCESS SARS-COV-2 IGG RESULT OF 0,33 S/CO WAS OBTAINED AND QUESTIONED BY CUSTOMER AS THE PATIENT WAS VACCINATED. PER CUSTOMER THE PATIENT HAD RECEIVED THE SECOND DOSE OF VACCINE FOURTEEN (14) DAYS BEFORE THE ACCESS RESULT (VACCINE NAME NOT PROVIDED). THEN THE CUSTOMER REPEATED THE SAMPLE PATIENT ON AN ALTERNATE METHODOLOGY (NAME NOT PROVIDED) WITH A DISCORDANT RESULT. NO FURTHER INFORMATION WAS PROVIDED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON 18FEB2021 USING REAGENT LOT 971261 AND CALIBRATOR LOT 988702. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2021. THE FSE DID NOT FIND ANY INSTRUMENT ISSUE WHICH MAY HAVE CONTRIBUTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567834 ↗
• MalfunctionMar 25, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 971261) RESULTS WERE GENERATED FOR SEVERAL PATIENTS ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)).THE ACCESS SARS-COV-2 IGG RESULTS WERE DISCORDANT WITH THE NEW ROCHE ELECSYS ANTI-SARS-COV-2 S ASSAY RESULTS, ALTHOUGH THEY BOTH TARGET ANTIBODIES ANTI-SPIKE PROTEIN. PER CUSTOMER¿S REPORT, THE DISCORDANCE CANNOT BE EXPLAINED BY THE LEVEL OF IGM AS THE IGM RESULTS ARE NON-REACTIVE. THE IGM RESULTS WERE NOT QUESTIONED.IN COMPARISON, THE RESULTS ARE CONCORDANT WITH THE ABBOTT RESULTS (98%).CUSTOMER REPORTED HAVING TESTED 107 SAMPLES WITH 8 SAMPLES WITH AN ¿EQUIVOCAL¿ RESULT WITH THE ACCESS SARS-COV-2 IGG ASSAY BUT REACTIVE WITH THE ROCHE ASSAY (DISCORDANT ACCORDING TO THE CUSTOMER) AND 54 SAMPLES WITH A ¿NON-REACTIVE¿ RESULT WITH THE ACCESS SARS-COV-2 IGG ASSAY BUT REACTIVE WITH THE ROCHE ASSAY (DISCORDANT ACCORDING TO THE CUSTOMER). NO INFORMATION ABOUT PATIENT CLINICAL FILE OR PCR DATA WAS PROVIDED. CUSTOMER INDICATED THAT OCCURRENCE DATE WAS (B)(6) 2021 BUT NO DATE/TIME OF ANALYSIS WAS PROVIDED.NO AFFEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567478 ↗
• MalfunctionMar 24, 2021Off-Label Use; Off-Label Use

  ON (B)(6) 2021 THE CUSTOMER REPORTED THAT NONREACTIVE COVID IGG (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 971262) PATIENT RESULTS WERE GENERATED ON THE CUSTOMER'S DXI (DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) FOR AN UNDISCLOSED NUMBER OF PATIENTS. THERE WAS NO REPORT OF INJURY OR ILLNESS TO THE PATIENT IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER CONSIDERED SOME OF THE RESULTS TO BE DISCORDANT TO A COMPETITOR METHOD (ABBOTT, SEMI-QUANTITATIVE METHOD, SPECIFIC ASSAY NOT PROVIDED). NO SPECIFIC TEST RESULTS WERE PROVIDED. THE PATIENTS HAD BEEN VACCINATED WITH THE SINOVAC CHINESE VACCINE (VACCINATION DATES NOT PROVIDED). NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562672 ↗
• MalfunctionMar 22, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 971262) RESULTS WERE GENERATED FOR SEVERAL VACCINATED PATIENTS ON THE CUSTOMER'S UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER A30260 AND SERIAL NUMBER (B)(4)).THE CUSTOMER REPORTED NON-REACTIVE SARS-COV-2 IGG PATIENT RESULTS FOR SEVERAL VACCINATED PATIENTS (NUMBER OF PATIENTS WAS NOT SPECIFIED) DISCORDANT TO RESULTS OBTAINED WITH IMMUNOFLUORESCENCE AND ELISA EUROIMMUN SARS-COV-2 IGG METHODS (NO DATA AND NO TIME OF ANALYSIS WERE REPORTED). REACTIVE RESULTS WERE EXPECTED. THE PATIENTS WERE VACCINATED WITH THE SINOVAC VACCINE.THE CUSTOMER PROVIDED AN EXAMPLE FOR ONE PATIENT SAMPLE (NO OCCURRENCE DATE WAS PROVIDED): THE ACCESS SARS-COV-2 IGG RESULT WAS 0.27 S/CO, THE IMMUNOFLUORESCENCE METHOD RESULT WAS 17 (CUT-OFF UNKNOWN, REACTIVE STATUS) AND THE ELISA EUROIMMUN SARS-COV-2 IGG RESULT WAS 37 (CUT-OFF 1.1, REACTIVE STATUS).NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON 21JAN2021 WITH REAGENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11539928 ↗
• MalfunctionMar 1, 2021False Negative Result; False Negative Result

  ON 17FEB2021 THE CUSTOMER REPORTED DISCORDANT SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 922628) RESULTS WERE GENERATED FOR ONE PATIENT ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER [PART NUMBER 81600N AND SERIAL NUMBER (B)(4)]. ON (B)(6) 2021 THE ACCESS SARS-COV-2 IGG RESULT OF 0,96 S/CO WAS OBTAINED. THEN THE CUSTOMER REPEATED THE SAMPLE WITH THE ABBOTT METHODOLOGY AND THE RESULT WAS DISCORDANT (7.05, REACTIVE). THE SAMPLE WAS REPEATED THE DAY AFTER IN DUPLICATE AND THE ACCESS SARS-COV-2 IGG RESULTS WERE 0.98 S/CO AND 1.08 S/CO. NO INFORMATION ABOUT PATIENT CLINICAL FILE OR PCR DATA WAS PROVIDED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE IF THE RESULT WAS RELEASED OUTSIDE THE LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON 10FEB2021. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED ON 10FEB2021. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391724 ↗