Access SARS-CoV-2 IgM C58957Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15099590738617), received between Oct 22, 2020 and Jun 21, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (6 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.

• MalfunctionJun 21, 2022High Test Results; High Test Results

  ON (B)(6) 2022 THE CUSTOMER REPORTED ONE QUESTIONED ELEVATED SARS-COV-2 IGM PATIENT RESULT (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 172016) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4). THE PATIENT IS VACCINATED (NO DATE PROVIDED, UNKNOWN VACCINE). THE CUSTOMER REPORTED THAT THE PATIENT PCR TEST WAS NEGATIVE. ON (B)(6) 2022, THE SARS-COV-2 IGM PATIENT RESULT WAS REACTIVE AT 2.54 UI/ML (QUESTIONED RESULT), A PREVIOUS RESULT WAS NON-REACTIVE AT 0.89 UI/ML ON (B)(6) 2022. THE PATIENT SAMPLES WERE ALSO TESTED WITH THE SARS-COV-2 IGG 1ST IS ASSAY AT THE SAME DATES WITH QUESTIONED POSITIVE RESULTS. A SECOND MEDWATCH REPORT WILL BE GENERATED TO ADDRESS THE SARS-COV-2 IGG 1ST IS RESULTS. THE PATIENT IS CMV IGG AND IGM POSITIVE AND EBV IGG POSITIVE AND EBV IGM NEGATIVE AT SAME DATES (B)(6) THE CUSTOMER SUSPECTED CROSS REACTIVITY. THERE WAS NO REPORT OF AN INJURY OR ILLNESS TO THE PATIENT ATTRIBUTABLE TO THE OUTPUT FROM THE DEVICE IN THIS EVENT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK PASSED ON 17MAY2022. NO QC DATA PROVIDED. CALIBRATION PASSED ON 27AP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753171 ↗
• MalfunctionApr 23, 2021False Positive Result; False Positive Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED PERSISTENT ELEVATED SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971256) RESULTS WERE GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (PART NUMBER A71456 AND SERIAL NUMBER (B)(4)). THE PHYSICIAN REPORTED THAT ONE PATIENT THAT PERSISTENT ELEVATED SARS-COV-2 IGM RESULTS POST COVID-19 INFECTION WHILE THE PATIENT¿S SPOUSE¿S SARS-COV-2 IGM RESULTS HAD RETURNED TO ZERO WEEKS PRIOR. THE DATA SUPPLIED BY THE PHYSICIAN ALSO INCLUDED SARS-COV-2 IGG RESULTS: (B)(6). NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. CALIBRATION, QC, AND SYSTEM CHECK DATA WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER DID NOT BELIEVE THE IGM VALUES OBTAINED ON THE INSTRUMENT TO BE INCORRECT. THE INQUIRY WAS REGARDING THE NORMAL TIME OF IGM REACTIVITY IN INDIVIDUALS. THERE WERE NO REPORTS OF OTHER INSTRUMENT ISSUES. THERE WERE NO REPORTS OF OTHER ISSUES WITH THIS ASSAY. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, CENTRIFUGATION, STORAGE AND OTHER SAMPLE RELATED INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716383 ↗
• MalfunctionApr 7, 2021False Positive Result; False Positive Result

  ON 18MAR2021 THE CUSTOMER REPORTED FALSE REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971287) RESULTS WERE GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). CUSTOMER REPORTED RESULTS OUTSIDE OF THE LABORATORY AND RESULTS WERE QUESTIONED. WHEN THE CUSTOMER REPEATED THE SAMPLES ON DXI 800 SERIAL NUMBER (B)(4), THE RESULTS WERE NON-REACTIVE. THE EXACT NUMBER OF PATIENTS RESULTS QUESTIONED WAS NOT PROVIDED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. CALIBRATION PASSED ON 18FEB2021 WITH REAGENT LOT 971287 AND CALIBRATOR LOT 922427. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORYS ESTABLISHED RANGES AT THE TIME OF THE EVENT. SYSTEM CHECK PASSED ON 15MAR2021. ON 17MAR2021 FROM 12:43 AM TO 01:16 AM, FOUR (4) "ASPIRATION MONITOR DETECTED POSSIBLE OBSTRUCTION" ERRORS OCCURRED JUST BEFORE THE EVENT. ALTHOUGH THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER, THIS ERROR MAY OCCASIONALLY OCCUR WITH SAMPLES WITH CLOTS AND FIBRINS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON 24MARCH2021 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626418 ↗
• MalfunctionFeb 22, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971287) RESULTS WERE GENERATED FOR ONE PATIENT ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE ACCESS SARS-COV-2 IGM RESULTS OBTAINED FOR THE PATIENT WERE 0.34 S/CO ON (B)(6) 2021 AND 0.31 S/CO ON (B)(6) 2021. PER CUSTOMER VERBAL'S REPORT, THE ACCESS RESULTS WERE DISCORDANT WITH REACTIVE ABBOTT RESULTS (ABBOTT PATIENT DATA WAS NOT PROVIDED). THE PATIENT HAD ALSO NON-REACTIVE ACCESS SARS-COV-2 IGG RESULTS. THE PATIENT EXPERIENCED FLU SYMPTOMS IN (B)(6) 2020. THERE WERE NO PCR RESULTS AVAILABLE. 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. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED ON (B)(6) 2021 AND CALIBRATION PASSED ON (B)(6) 2021 WITH REAGENT LOT 971287 AND CALIBRATOR LOT 922426. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE INFORMATION SUCH AS SAMPLE COLLECTION TUBE USED, CE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359284 ↗
• MalfunctionFeb 15, 2021False Positive Result; False Positive Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED ONE NON-REPRODUCIBLE REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971287) RESULT WAS GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE ACCESS RESULT OF 11.49 S/CO (REPORTABLE RANGE: REACTIVE =1.0 S/CO) WAS OBTAINED ON (B)(6) 2021. UPON REPEAT THE FOLLOWING DAY, A RESULT AT 0.14 S/CO WAS OBTAINED ON SAME ANALYZER AND A RESULT AT 0.18 S/CO WAS OBTAINED ON INSTRUMENT SERIAL NUMBER (B)(4). THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2021 ON INITIAL INSTRUMENT WITH A RESULT AT 0.17 S/CO. THE SARS-COV-2 IGG RESULT IS NON-REACTIVE AND IS NOT QUESTIONED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULT WAS REPORTED OUT OF THE LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON (B)(6) 2021 WITH REAGENT LOT 971287 AND CALIBRATOR LOT 922427. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. CARRYOVER TEST PASSED ON (B)(6) 2021. SYSTEM CHECK PASSED ON (B)(6) 2021. SERVICE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11328043 ↗
• MalfunctionFeb 5, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NEGATIVE COVID IGM RESULTS (ACCESS SARS-COV-2 IGM, PART NUMBER C58957 AND LOT NUMBER 971256) WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) FOR AN UNKNOWN NUMBER OF PATIENTS WHO HAD POSITIVE COVID IGM RESULTS FROM AN ALTERNATIVE PLATFORM (ALTERNATIVE PLATFORM INFORMATION NOT PROVIDED). 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. 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 11286012 ↗
• MalfunctionFeb 5, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58957, LOT NUMBER 971256) RESULTS WERE GENERATED FOR SEVERAL PATIENTS ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE ACCESS SARS-COV-2 IGM RESULTS WERE DISCORDANT WITH ALTERNATE METHODS, ALTERNATE METHODS USED ARE UNKNOWN. THE RESULTS OBTAINED BY THE CUSTOMER WERE NOT PROVIDED AND THE NUMBER OF PATIENTS IS UNKNOWN. 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 (B)(6) 2020 WITH REAGENT LOT 971256 AND CALIBRATOR LOT 922426. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED ON (B)(6) 2021. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE INFORMATION SUCH AS SAMPLE COLLECTION TUBE USED, CENTRIFUGATION TIME AND SPEED, STORAGE OR HANDLING WAS NOT PROVIDED BY THE CUSTOMER. NOTE: THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGM RESULTS ON A SECOND DXI ANALYZER SERIAL NUMBER 60643

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11285415 ↗
• MalfunctionJan 15, 2021False Positive Result

  ON (B)(6) 2020 THE CUSTOMER REPORTED QUESTIONED POSITIVE COVID IGM RESULTS (ACCESS SARS-COV-2 IGM, PART NUMBER C58957 AND LOT NUMBER 971257) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 8386220 AND SERIAL NUMBER (B)(4)) FOR THREE PATIENTS. 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 PATIENT SAMPLES WERE TESTED AT TWO OTHER SITES; ONE PATIENT TESTS REPEATED POSITIVE AT BOTH SITES AND TWO PATIENTS' SAMPLES TESTED NEGATIVE AT BOTH SITE. SEE FOLLOWING SECTION FOR DETAILS ON TESTING. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS 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 11178228 ↗
• MalfunctionJan 8, 2021False Negative Result; False Negative Result

  ON (B)(6) 2020 THE CUSTOMER REPORTED NEGATIVE COVID IGM RESULTS (ACCESS SARS-COV-2 IGM, PART NUMBER C58957 AND LOT NUMBER 971257) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR TWO PATIENTS WHO HAD POSITIVE COVID IGM RESULTS FROM AN ALTERNATIVE PLATFORM (ABBOTT ARCHITECT). 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. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS 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 11140782 ↗
• MalfunctionJan 5, 2021False Positive Result; False Positive Result

  ON (B)(6) 2020, THE CUSTOMER REPORTED ONE NON-REPRODUCIBLE REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971246) RESULT WAS GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (REFURBISHED) (PART NUMBER 386220 AND SERIAL NUMBER (B)(4)). THE ACCESS RESULT OF 1.77 S/CO (REPORTABLE RANGE: REACTIVE =1.0 S/CO) WAS OBTAINED ON (B)(6) 2020, AT 11:23 AM. UPON REPEAT, A RESULT AT 0.52 S/CO (AT 01:41 PM) WAS OBTAINED. THE ACCESS SARS-COV-2 IGG RESULT WAS NON-REACTIVE. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULT WAS REPORTED OUT OF THE LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED TWICE ON 7DEC2020 AT 3:06 PM, AND 3:54 PM, WITH REAGENT LOT 971246 AND CALIBRATOR LOT 922426. %CV ON THE C0 FOR THE FIRST CALIBRATION WAS 32.54%. %CV ON THE C0 FOR THE SECOND CALIBRATION WAS 4.13 %. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED ON 7DEC2020. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11115960 ↗
• MalfunctionNov 4, 2020High Test Results; High Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED ERRONEOUS NON-REACTIVE COVID (SARS-COV-2 IGM ASSAY, PART NUMBER C58957 AND LOT NUMBER 971230) RESULTS FOR SEVEN PATIENTS WERE GENERATED ON THE CUSTOMER'S REFURBISHED ACCESS2 IMMUNOASSAY ANALYZER (PART NUMBER 386220 AND SERIAL NUMBER (B)(4)). THE CUSTOMER DID NOT INDICATE WHETHER THE NON-REACTIVE COVID RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT TREATMENT OR MANAGEMENT FOR ANY OF THE PATIENTS IN CONJUNCTION WITH THE EVENT. THERE WERE NO HARDWARE ERRORS OR OTHER ASSAY ISSUES REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND LEVEL 2 QUALITY CONTROL (QC) WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER'S LEVEL 1 QC WAS OUT OF SPECIFICATIONS HIGH BUT RECOVERED WITHIN SPECIFICATIONS WHEN THE SYSTEM WAS RECALIBRATED. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. CUSTOMER DID NOT PROVIDE SAMPLE INFORMATION SUCH AS SAMPLE TUBE MANUFACTURER, CENTRIFUGATION, HANDLING OR OTHER SAMPLE PROCESSING INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10786521 ↗
• MalfunctionOct 26, 2020False Negative Result; False Negative Result

  ON 08OCT2020 THE CUSTOMER REPORTED ONE NON-REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971217) RESULT WAS GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (REFURBISHED) (PART NUMBER 386220 AND SERIAL NUMBER (B)(4)). THE ACCESS RESULT OF 0.28 S/CO (REPORTABLE RANGE: REACTIVE =1.0 S/CO) WAS OBTAINED ON (B)(6) 2020 AT 10:06 AM. THE PATIENT DID NOT PRESENT ANY SYMPTOM BUT HAD A POSITIVE PCR. THE SARS-COV-2 IGG RESULT WAS ALSO NON-REACTIVE (0.02 S/CO AT 10:00 AM). THE SAMPLE FOR PCR TESTING WAS COLLECTED THE SAME DAY AS THE SAMPLE FOR SEROLOGY TESTING. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE REPORTED OUT OF THE LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON (B)(6) 2020 WITH REAGENT LOT 971217 AND CALIBRATOR LOT 922425. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED ON (B)(6) 2020. THERE WAS NO ISSUE WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734514 ↗
• MalfunctionOct 22, 2020False Positive Result; False Positive Result

  ON (B)(6) 2020, THE CUSTOMER REPORTED ONE REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971217) RESULT WAS GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (REFURBISHED) (PART NUMBER 386220 AND SERIAL NUMBER (B)(4)). THE ACCESS RESULT OF 1.47 S/CO (REPORTABLE RANGE: REACTIVE =1.0 S/CO) WAS OBTAINED ON (B)(6) 2020. THE PATIENT DID NOT PRESENT ANY SYMPTOM AND HAD A NEGATIVE PCR. THE SARS-COV-2 IGG RESULT WAS ALSO NON-REACTIVE (0.02 S/CO). THE SAMPLE FOR PCR TESTING WAS COLLECTED THE SAME DAY AS THE SAMPLE FOR SEROLOGY TESTING. NO AFFECT TO PATIENTS, OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE REPORTED OUT OF THE LABORATORY. NO HARDWARE ERRORS, OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON (B)(6) 2020 WITH REAGENT LOT 971217 AND CALIBRATOR LOT 922425. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED ON 5OCT2020. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717697 ↗