Access SARS-CoV-2 IgG II C69057Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 15099590742744), received between Mar 8, 2021 and Jan 25, 2022 — classified as 33 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (25 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2022False Negative Result; False Negative Result

  ON 17JAN2022 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG (ACCESS SARS-COV-2-IGG II, PART NUMBER C69057 AND LOT NUMBER 124814) RESULTS WERE GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER 606051) FOR TWO PATIENTS. THE NON-REACTIVE PATIENT RESULTS WERE DISCORDANT TO RESULTS GENERATED USING THE SARS-COV-2 IGG II QUANT ABBOTT ARCHITECT METHOD. THERE WAS NO REPORT OF CHANGE TO PATIENT CARE OR TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE PATIENTS HAD BEEN VACCINATED AGAINST SARS-COV-2, AND HAD RECEIVED SUPPLEMENTAL DOSES OF COVISHIELD VACCINATIONS (SPECIFIC DATES OF VACCINATIONS WERE NOT PROVIDED). NO OTHER PATIENT INFORMATION WAS PROVIDED. THE EVENT LOG WAS PROVIDED SHOWING SUBSTRATE DISPENSE ERRORS WHICH OCCURRED BEFORE THE ISSUE OCCURRED. SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. IT WAS NOTED THAT THE CUSTOMER WAS USING A CALIBRATION WHICH HAD FLAGS INDICATING SUBSTRATE REAGENT WAS EXPIRED AT THE TIME OF CALIBRATION. THE CUSTOMER WAS NOT RUNNING QUALITY CONTROL AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLEC

  Patient problems: Insufficient Information

  MAUDE report 13351297 ↗
• MalfunctionOct 15, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED THAT QUESTIONED ERRATIC COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124558) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021 FOR TWO PATIENTS. THE INITIAL RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT CARE OF TREATMENT IN CONNECTION WITH THIS EVENT. THE PATIENTS WERE REDRAWN THE NEXT DAY AND RESULTS WHICH WERE DISCORDANT TO THE ORIGINAL RESULTS WERE OBTAINED. THE CUSTOMER THEN QUESTIONED THE ORIGINAL RESULTS. THE CUSTOMER THEN RETESTED THE ORIGINAL SAMPLES AND OBTAINED DIFFERENT RESULTS. 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. SAMPLES WERE COLLECTED AND INITIALLY TESTED IN LITHIUM HEPARIN GEL TUBES; AND REPEAT TESTING WAS PERFORMED USING FROZEN/THAWED ALIQUOTS OF THESE SAMPLES. SAMPLES WERE CENTRIFUGED FOR 5 MINUTES AT ROOM TEMPERA

  Patient problems: Insufficient Information

  MAUDE report 12641506 ↗
• MalfunctionOct 14, 2021False Negative Result; False Negative Result

  ON 07OCTOBER2021 THE CUSTOMER REPORTED A QUESTIONED LOW COVID IGG RESULT (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124351) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, REFURBISHED, PART NUMBER 386220 AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021 FOR A PATIENT WHO HAD BEEN PREVIOUSLY VACCINATED AGAINST COVID. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULT OF 16.16 AU/ML WAS RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT CARE OF TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE PATIENT HAD BEEN VACCINATED AGAINST SARS-COV-2; THE PATIENT HAD RECEIVED A 2ND DOSE OF THE COVISHIELD VACCINE 15 DAYS PRIOR TO THE GENERATION OF THE RESULT OF 16.16 AU/ML. THE CUSTOMER REPORTED THE PATIENT DID NOT HAVE A HISTORY OF COVID INFECTION. THE CUSTOMER REPORTED THE PATIENT SAMPLE HAD GENERATED A REACTIVE RESULT OF 1300 U/ML ON A ROCHE PLATFORM (THE ELECSYS ANTI-SARS-COV-2 S ASSAY). NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. IT WAS NOTED THAT THE CUSTOMER WAS USING AN EXPIRED CALIBRATION CURVE AT THE TIME OF THE EVENT. THE CUSTOMER WAS ALSO USING AN EXPIRED COVID REAGENT PACK AT THE TIME

  Patient problems: Insufficient Information

  MAUDE report 12636085 ↗
• MalfunctionSep 10, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED A NON-REACTIVE COVID IGG RESULT (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 922974) WAS GENERATED ON THE CUSTOMER'S DXI (UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021 FOR A PATIENT WHO HAD BEEN PREVIOUSLY VACCINATED AGAINST COVID. 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 THAT THE PATIENT HAD BEEN VACCINATED AGAINST SARS-COV-2; INITIAL ASTRAZENECA SARS-COV-2 VACCINE WAS ADMINISTERED IN EARLY (B)(6) WITH VACCINATION SERIES COMPLETED IN EARLY (B)(6). CUSTOMER REPORTED THE PATIENT HAD A REACTIVE COVID RESULT USING AN ALTERNATE PLATFORM, ABBOTT ALINITY SARS-COV2-IGG II QUANTITATIVE ASSAY; THE RESULT OF 3153.9 AU/ML WAS REACTIVE (POSITIVE IF 50 = AU). 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

  Patient problems: Insufficient Information

  MAUDE report 12453947 ↗
• MalfunctionAug 17, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021, THE CUSTOMER REPORTED THAT ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124351) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER - REFURBISHED, PART NUMBER A65531 AND SERIAL NUMBER (B)(4)). 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 WENT TO ANOTHER LABORATORY WHERE HE HAD A SAMPLE TESTED BY ANOTHER METHODOLOGY (COVIPROTECT SARS COV2 SPIKE PROTEIN ANTIBODY QUANTITATIVE (SERUM. CMIA)) ON (B)(6) 2021 AND A POSITIVE RESULT WAS OBTAINED. THE CUSTOMER REPORTED THAT THE PATIENT HAD BEEN VACCINATED AGAINST SARS-COV-2 WITH THE COVISHIELD VACCINE 4-6 WEEKS 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 AD THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE INFORMATION SUCH COLLECTION AND HANDLING INFORMATION WA

  Patient problems: Insufficient Information

  MAUDE report 12331706 ↗
• MalfunctionAug 13, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124558) WERE GENERATED ON THE CUSTOMER'S DXI (DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). 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 THAT THE PATIENT HAD BEEN VACCINATED AGAINST SARS-COV-2 WITH THE ASTRAZENECA VACCINE IN EARLY JUNE. CUSTOMER REPORTED THE PATIENT HAD A REACTIVE COVID RESULT WITH A SAMPLE COLLECTED (B)(6) 2021 AND TESTED ON THE ROCHE ANTI-SARS-COV-2 S TOTAL METHOD ON (B)(6) 2021. THE CUSTOMER ALSO REPORTED A SAMPLE COLLECTED AND TESTED ON (B)(6) 2021 AND TESTED USING THE ACCESS COVID IGG ASSAY HAD ALSO HAD A NONREACTIVE RESULT. 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 AD THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE WAS NOTED TO BE COLLECTED IN A 5 ML BD VACUET

  Patient problems: Insufficient Information

  MAUDE report 12318689 ↗
• MalfunctionAug 10, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124351) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 ANALYZER (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER A65531 AND SERIAL NUMBER (B)(4)) FOR SIX PATIENTS; HOWEVER, THE CUSTOMER ONLY PROVIDED DETAILED RESULTS FOR TWO OF THESE PATIENTS. SEE FULL IDENTIFIER CASE (B)(4) FOR OTHER PATIENT RESULTS. 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. CUSTOMER DECLINED TO PROVIDE INFORMATION REGARDING HISTORY OF COVID-19 INFECTION. 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. 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 12304054 ↗
• MalfunctionAug 10, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124351) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 ANALYZER (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER A65531 AND SERIAL NUMBER (B)(4)) FOR SIX PATIENTS; HOWEVER, THE CUSTOMER ONLY PROVIDED DETAILED RESULTS FOR TWO OF THESE PATIENTS. SEE FULL IDENTIFIER CASE (B)(6) FOR OTHER PATIENT RESULTS. 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. CUSTOMER DECLINED TO PROVIDE INFORMATION REGARDING HISTORY OF COVID-19 INFECTION. 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. 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 12303994 ↗
• MalfunctionAug 3, 2021Low Test Results; Low Test Results

  ON 24JULY2021 THE CUSTOMER REPORTED THAT LESS REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124558) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 ANALYZER (ACCESS 2 IMMUNOASSAY ANALYZER, REFURBISHED, PART NUMBER 386220 AND SERIAL NUMBER (B)(4)) THAN WERE GENERATED ON A COMPETITOR METHOD. 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 INDICATED THE PATIENT HAD PREVIOUSLY BEEN VACCINATED; HOWEVER, VACCINE MANUFACTURER AND VACCINE DATES ADMINISTERED WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED THAT A POSITIVE SARS COV2 ANTIBODY TEST RESULT WAS OBTAINED WHEN THE PATIENT SAMPLE WAS TESTED ON ANOTHER PLATFORM (COVIPROTECT-SARS COV2 ANTIBODY ECLIA METHODOLOGY). 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

  Patient problems: Insufficient Information

  MAUDE report 12271439 ↗
• MalfunctionAug 3, 2021False Negative Result; False Negative Result

  ON 24JULY2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124558) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 ANALYZER (ACCESS 2 IMMUNOASSAY ANALYZER, REFURBISHED, PART NUMBER 386220 AND SERIAL NUMBER (B)(4)). 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 INDICATED THE PATIENT HAD PREVIOUSLY BEEN VACCINATED; HOWEVER, VACCINE MANUFACTURER AND VACCINE DATES ADMINISTERED WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED THAT A POSITIVE SARS COV2 ANTIBODY TEST RESULT WAS OBTAINED WHEN THE PATIENT SAMPLE WAS TESTED ON ANOTHER PLATFORM (COVIPROTECT-SARS COV2 ANTIBODY ECLIA METHODOLOGY). 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, CE

  Patient problems: Insufficient Information

  MAUDE report 12271410 ↗
• MalfunctionAug 3, 2021False Negative Result; False Negative Result

  ON 24JULY2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124558) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 ANALYZER (ACCESS 2 IMMUNOASSAY ANALYZER, REFURBISHED, PART NUMBER 386220 AND SERIAL NUMBER (B)(4)). 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 INDICATED THE PATIENT HAD PREVIOUSLY BEEN VACCINATED; HOWEVER, VACCINE MANUFACTURER AND VACCINE DATES ADMINISTERED WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED THAT A POSITIVE SARS COV2 ANTIBODY TEST RESULT WAS OBTAINED WHEN THE PATIENT SAMPLE WAS TESTED ON ANOTHER PLATFORM (COVIPROTECT-SARS COV2 ANTIBODY ECLIA METHODOLOGY). 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, CE

  Patient problems: Insufficient Information

  MAUDE report 12271379 ↗
• MalfunctionJul 22, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 922974) WERE GENERATED ON THE CUSTOMER'S DXI 600 (UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER A30260 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT ON (B)(6) 2021. 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 THAT THAT THE PATIENT HAD BEEN VACCINATED AGAINST SARS-COV-2 WITH THE ASTRAZENECA VACCINE. VACCINE ADMINISTRATION DATES WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER DID REPORT THAT A REACTIVE SARS-COV-2 RESULT WAS OBTAINED ON (B)(6) 2021 WITH AN ALTERNATE METHOD (DIASORIN LIAISON SARS-COV-2 TRIMERICS IGG ASSAY). NO HARDWARE ERRORS 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 OTHER ASSAYS WAS REPORTED 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 T

  Patient problems: Insufficient Information

  MAUDE report 12211038 ↗
• MalfunctionJul 19, 2021False Negative Result; False Negative Result

  ON 12JULY2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124351) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 ANALYZER (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) ON 08JULY2021. 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 THAT THAT THE PATIENT HAD BEEN VACCINATED AGAINST SARS-COV-2; HOWEVER, CUSTOMER DID NOT PROVIDE VACCINATION DATES OR SPECIFIC VACCINATION ADMINISTERED. CUSTOMER REPORTED THE PATIENT HAD A REACTIVE COVID RESULT USING AN ALTERNATE PLATFORM, THE COVIPROTECT SARS COV2 QUANTITATIVE ANTIBODY (CIMA) ASSAY. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL NOT PROVIDED 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 INFO

  Patient problems: Insufficient Information

  MAUDE report 12189836 ↗
• MalfunctionJul 19, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057, LOT NUMBER 124351) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 ANALYZER (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021. 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 THAT THAT THE PATIENT HAD BEEN VACCINATED AGAINST SARS-COV-2; HOWEVER, CUSTOMER DID NOT PROVIDE VACCINATION DATES OR SPECIFIC VACCINATION ADMINISTERED. CUSTOMER REPORTED THE PATIENT HAD A REACTIVE COVID RESULT USING AN ALTERNATE PLATFORM, VITROS 5600 INTEGRATED SYSTEM (E.C.I.A.). NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL NOT PROVIDED 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 PR

  Patient problems: Insufficient Information

  MAUDE report 12189819 ↗
• MalfunctionJul 6, 2021False Negative Result; False Negative Result

  ON 18JUN2021 THE CUSTOMER REPORTED REPRODUCIBLE NON-REACTIVE SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 922974) RESULTS WERE GENERATED FOR ONE VACCINATED PATIENT ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT THE INITIAL ACCESS SARS-COV-2 IGG II RESULT WAS NON-REACTIVE AT 6.72 AU/ML (REACTIVE: = 10.0 AU/ML) OBTAINED ON (B)(6) 2021. THE RESULT WAS DISCORDANT WITH THE ABBOTT SARS-COV-2 IGG RESULT OF 235.4 AU/ML. A SECOND SAMPLE FROM THIS PATIENT WAS TESTED ON (B)(6) 2021. THE ACCESS SARS-COV-2 IGG II RESULT WAS 6.97 AU/ML AND THE ABBOTT SARS-COV-2 IGG RESULT WAS 419.9 AU/ML. THE PATIENT WAS VACCINATED WITH THE SPUTNIK V VACCINE. 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 SYSTEM CHECK OR QUALITY CONTROL (QC) DATA WAS PROVIDED. CALIBRATION PASSED ON 26JUN2021 WITH REAGENT LOT 922974 AND CALIBRATOR LOT 124322. TWO PATIENT SAMPLES WERE SENT TO THE COMPLAINT HANDLING UNIT FOR INVESTIGATION. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120323 ↗
• MalfunctionJul 6, 2021Low Test Results; Low Test Results

  ON 09JUN2021 THE CUSTOMER REPORTED ONE LOW SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 124351) RESULT WAS GENERATED FOR ONE VACCINATED PATIENT ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT THE INITIAL ACCESS SARS-COV-2 IGG II RESULT WAS 10.05 AU/ML (REACTIVE: = 10.0 AU/ML) OBTAINED ON (B)(6) 2021. THE RESULT WAS CLINICALLY CONCORDANT WITH THE ABBOTT AND MAGLUMI RESULTS, HOWEVER, THE CUSTOMER REPORTED THAT THE QUANTITATIVE RESULTS WERE HIGHER WITH THOSE METHODS: ¿ABBOTT SARS-COV2 RESULT: 101.4 BAU/ML (CUT OFF 7.1 BAU/ML) OBTAINED ON (B)(6) 2021. ¿MAGLUMI COV-2 RBD IGG RESULT: 84.45 BAU/ML (CUT OFF 4.3) OBTAINED ON (B)(6) 2021. THE PATIENT RECEIVED 2 DOSES (ABOUT (B)(6) 2021) OF ASTRAZENECA VACCINE. 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. SYSTEM CHECKS PASSED ON 11JUN AND 12JUN2021. CALIBRATION PASSED ON 12MAY2021 WITH REAGENT LOT 124351 AND CALIBRATOR LOT 922915. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120322 ↗
• MalfunctionJun 24, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 922974) RESULTS WERE GENERATED FOR TWO VACCINATED PATIENTS ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT THE INITIAL NON-REACTIVE SARS-COV-2 IGG II RESULT FOR THE PATIENT ONE WAS 7.2 AU/ML OBTAINED ON (B)(6) 2021 (NON REACTIVE: < 10 AU/ML). THIS RESULT WAS DISCORDANT WITH THE DIASORIN IGG TRIMERICS RESULT OF 246 UI/ML (CUT-OFF FOR POSITIVE: =33.8 UI/ML) OBTAINED ON (B)(6) 2021. THE PATIENT SAMPLE WAS REPEATED AFTER A PREVENTIVE MAINTENANCE AT 6.9 AU/ML ON (B)(6) 2021. (B)(6). TWO (2) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS BOTH PATIENTS, THIS REPORT ADDRESS THE RESULTS OF PATIENT ONE: MEDWATCH NUMBER ¿2122870-2021-00091¿ WILL ADDRESS PATIENT ONE. MEDWATCH NUMBER ¿2122870-2021-00092¿ WILL ADDRESS PATIENT TWO. 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. SYSTEM CHECK PASSED ON (B)(6) 2021. CALIBRATION PASSED ON (B)(6) 2021 WITH REA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12057035 ↗
• MalfunctionJun 24, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 922974) RESULTS WERE GENERATED FOR TWO VACCINATED PATIENTS ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT THE INITIAL NON-REACTIVE SARS-COV-2 IGG II RESULT FOR THE PATIENT ONE WAS 7.2 AU/ML OBTAINED ON (B)(6) 2021 (NON REACTIVE: < 10 AU/ML). THIS RESULT WAS DISCORDANT WITH THE DIASORIN IGG TRIMERICS RESULT OF 246 UI/ML (CUT-OFF FOR POSITIVE: =33.8 UI/ML) OBTAINED ON (B)(6) 2021. THE PATIENT SAMPLE WAS REPEATED AFTER A PREVENTIVE MAINTENANCE AT 6.9 AU/ML ON (B)(6) 2021. THE INITIAL NON-REACTIVE SARS-COV-2 IGG II RESULT FOR THE PATIENT TWO WAS 7.0 AU/ML ON (B)(6) 2021. THIS RESULT WAS DISCORDANT WITH THE DIASORIN IGG TRIMERICS RESULT OF 230 UI/ML UI/ML (CUT-OFF FOR POSITIVE: =33.8 UI/ML). NO DATA WAS PROVIDED. BOTH PATIENT RECEIVED TWO DOSES OF THE PFIZER VACCINE, THE LATEST DOSE WAS RECEIVED ON (B)(6) 2021 FOR PATIENT ONE AND ON (B)(6) 2021 FOR PATIENT TWO. TWO (2) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS BOTH PATIENTS, THIS REPORT ADDRESS THE RESULTS OF PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12057034 ↗
• MalfunctionJun 15, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021, THE CUSTOMER REPORTED ONE NON-REACTIVE SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 124141) 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 CUSTOMER REPORTED A NON-REACTIVE SARS-COV-2 IGG II PATIENT RESULT OF 2.9 AU/ML OBTAINED ON (B)(6) 2021 (NON REACTIVE: < 10 AU/ML). THIS RESULT WAS DISCORDANT WITH THE ABBOTT SARS-COV-2 IGG RESULT OF 21.47 UI (BAU)/ML [151.2 AU/ML]). CUT-OFF IS 50 AU/ML. THE PATIENT RECEIVED TWO DOSES OF THE PFIZER VACCINE, THE LATEST DOSE WAS RECEIVED AT THE END OF (B)(6). 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. SYSTEM CHECK PASSED ON 31MAY2021. CALIBRATION PASSED ON 2APR2021 WITH REAGENT LOT 124141 AND CALIBRATOR LOT 922915. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORYS ESTABLISHED RANGES. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998119 ↗
• MalfunctionJun 4, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REACTIVE SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 922974) RESULTS WERE GENERATED FOR THREE VACCINATED PATIENTS ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). FOR ONE PATIENT, THE CUSTOMER DID THE COMPARISON WITH THE ROCHE TOTAL IGG + IGM AND THE NON-REACTIVE ACCESS RESULT WAS DISCORDANT WITH THE ROCHE ANTI-SARS-COV-2 S TOTAL METHOD RESULT. REFER TO SECTION BELOW. 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. SYSTEM CHECK PASSED ON (B)(6) 2021. CALIBRATION PASSED ON (B)(6) 2021 WITH REAGENT LOT 922974 AND CALIBRATOR LOT 922915. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938424 ↗
• MalfunctionMay 10, 2021Low Test Results; Low Test Results

  ON 13APR2021 THE CUSTOMER REPORTED THAT ON (B)(6) 2021 AND AGAIN ON (B)(6) 2021, NONREACTIVE COVID IGG II (ACCESS SARS-COV-2 IGG II, PART NUMBER C69057 AND LOT NUMBER 124141) PATIENT RESULTS (8.76 AU/ML; CUT-OFF 10 AU/ML ((B)(6) 2021) AND 9.17 AU/ML; CUTOFF 10 AU/ML ((B)(6) 2021) ) WERE GENERATED ON THE CUSTOMER'S DXI 800 (UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THERE WAS NO REPORT OF INJURY OR ILLNESS TO THE PATIENT IN CONJUNCTION WITH THIS EVENT. THE PATIENT SAMPLE WAS ALSO TESTED ON A COMPETITOR PLATFORM (ROCHE METHOD; RESULTS OF 15.2 (UNITS NOT PROVIDED) (CUTOFF NOT PROVIDED) WERE OBTAINED ON (B)(6) 2021). THE PATIENT HAD BEEN VACCINATED WITH THE ASTRAZENECA VACCINE FIVE WEEKS PRIOR TO TESTING. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. REVIEW OF CUSTOMER-SUPPLIED ARCDATA FILE WAS UNREMARKABLE AND DID NOT HIGHLIGHT A PERFORMANCE ISSUE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECT

  Patient problems: Insufficient Information

  MAUDE report 11797941 ↗
• MalfunctionMar 25, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 922896) RESULTS WERE GENERATED FOR SEVERAL PATIENTS ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). FIFTY-ONE (51) PATIENT SAMPLES WERE TESTED ON THE ACCESS SARS-COV-2 IGG II ASSAY AND COMPARED TO THE ROCHE ELECSYS ANTI-SARS-COV-2 S AND THE ORTHO VITROS SARS-COV-2 IGG ASSAY. EIGHTEEN (18) SAMPLES ARE SUSPECTED TO BE FALSE NON-REACTIVE. NO CLINICAL DATA WAS AVAILABLE. REFER TO RELEVANT TESTS SECTION BELOW. SIX (6) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS CUSTOMER REPORTS OF DISCORDANT NON-REACTIVE ACCESS SARS-COV-2 IGG II RESULTS OBTAINED ON DIFFERENT DATES. THIS REPORT ADDRESS THE DISCORDANT NON-REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULTS OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER ¿2122870-2021-00034¿ WILL ADDRESS DISCORDANT REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULTS OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER ¿2122870-2021-00035¿ WILL ADDRESS DISCORDANT REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULT OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER ¿2122870-2021-00036¿ WILL ADDRESS DISCOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567480 ↗
• MalfunctionMar 25, 2021False Positive Result; False Positive Result

  ON (B)(6) 2021, THE CUSTOMER REPORTED DISCORDANT REACTIVE SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 922896) RESULTS WERE GENERATED FOR TWO PATIENTS ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). FIFTY-ONE (51) PATIENT SAMPLES WERE TESTED ON THE ACCESS SARS-COV-2 IGG II ASSAY AND COMPARED TO THE ROCHE ELECSYS ANTI-SARS-COV-2 S AND THE ORTHO VITROS SARS-COV-2 IGG ASSAY. TWO (2) SAMPLES ARE SUSPECTED TO BE FALSE REACTIVE BUT THE RESULTS ARE CONCORDANT WITH THE VITROS RESULTS. NO PCR DATA WAS AVAILABLE. REFER TO RELEVANT TESTS SECTION BELOW. TWO (2) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS CUSTOMER REPORTS OF DISCORDANT REACTIVE ACCESS SARS-COV-2 IGG II RESULTS OBTAINED ON DIFFERENT DATES. THIS REPORT ADDRESS THE DISCORDANT REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULT OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER 2122870-2021-00033 WILL ADDRESS DISCORDANT REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULT OBTAINED ON (B)(6) 2021. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE IF THE RESULTS WERE RELEASED OUTSIDE THE LABORATORY. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567477 ↗
• MalfunctionMar 25, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 922896) RESULTS WERE GENERATED FOR SEVERAL PATIENTS ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). FIFTY-ONE (51) PATIENT SAMPLES WERE TESTED ON THE ACCESS SARS-COV-2 IGG II ASSAY AND COMPARED TO THE ROCHE ELECSYS ANTI-SARS-COV-2 S AND THE ORTHO VITROS SARS-COV-2 IGG ASSAY. EIGHTEEN (18) SAMPLES ARE SUSPECTED TO BE FALSE NON-REACTIVE. NO CLINICAL DATA WAS AVAILABLE. REFER TO RELEVANT TESTS SECTION BELOW. SIX (6) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS CUSTOMER REPORTS OF DISCORDANT NON-REACTIVE ACCESS SARS-COV-2 IGG II RESULTS OBTAINED ON DIFFERENT DATES. THIS REPORT ADDRESS THE DISCORDANT NON-REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULTS OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER 2122870-2021-00035 WILL ADDRESS DISCORDANT REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULT OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER 2122870-2021-00036 WILL ADDRESS DISCORDANT REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULTS OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER 2122870-2021-00037 WILL ADDRESS DISCOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567476 ↗
• MalfunctionMar 25, 2021False Negative Result; False Negative Result

  ON (B)(6) 2021 THE CUSTOMER REPORTED DISCORDANT NON-REACTIVE SARS-COV-2 IGG II (ACCESS SARS-COV-2 IGG II ASSAY, PART NUMBER C69057, LOT NUMBER 922896) RESULTS WERE GENERATED FOR SEVERAL PATIENTS ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). FIFTY-ONE (51) PATIENT SAMPLES WERE TESTED ON THE ACCESS SARS-COV-2 IGG II ASSAY AND COMPARED TO THE ROCHE ELECSYS ANTI-SARS-COV-2 S AND THE ORTHO VITROS SARS-COV-2 IGG ASSAY. EIGHTEEN (18) SAMPLES ARE SUSPECTED TO BE FALSE NON-REACTIVE. NO CLINICAL DATA WAS AVAILABLE. REFER TO RELEVANT TESTS SECTION BELOW. SIX (6) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS CUSTOMER REPORTS OF DISCORDANT NON-REACTIVE ACCESS SARS-COV-2 IGG II RESULTS OBTAINED ON DIFFERENT DATES. THIS REPORT ADDRESS THE DISCORDANT NON-REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULT OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER 2122870-2021-00034 WILL ADDRESS DISCORDANT REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULTS OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER 2122870-2021-00035 WILL ADDRESS DISCORDANT REACTIVE ACCESS SARS-COV-2 IGG II PATIENT RESULT OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER 2122870-2021-00036 WILL ADDRESS DISCORD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567475 ↗