ARCHITECT 4P54-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380740007799), received between Aug 5, 2016 and Jan 2, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (18 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ARCHITECT HBSAG QUALITATIVE RESULTS WHICH QUESTIONED BY THE PHYSICIAN FOR SEVERAL PATIENTS. THE ONE RESULT EXAMPLE PROVIDED WERE: INITIAL=1.23 S/CO (> OR =1.00 S/CO=REACTIVE) /REPEATED AFTER REDRAWN MULTIPLE TIMES SAME PATIENT=1.6, 1.7 AND 1.33 S/CO. HBSAG QUAL CONFIRMATORY C2=1.55 S/CO; % NEUTRALIZATION=99% (C2=> OR =0.70 S/CO AND % NEUTRALIZATION=> OR =50%=CONFIRMED POSITIVE) ADDITIONAL INFORMATION PROVIDED: ALL OTHER HEPATITIS B MARKERS ARE NEGATIVE (NO ACTUAL RESULTS PROVIDED) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945733 ↗
• MalfunctionAug 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024, SID (B)(6), INITIAL HBSAG= REACTIVE; REPEATED IN DUPLICATE= REACTIVE; NEUTRALIZING CONFIRMATORY TESTING= REACTIVE. THE PATIENT SAMPLE WAS SENT OUT TO A REFERENCE LAB ON (B)(6) 2024, HBSAG CAME BACK NON-REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055844 ↗
• MalfunctionOct 17, 2023False Positive Result; High Test Results; False Positive Result; High Test Results

  THE CUSTOMER OBSERVED FALSELY REACTIVE ARCHITECT HBSAG RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR MULTIPLE PATIENT SAMPLES. ADDITIONALLY, THE CUSTOMER REPORTED AN INCREASE IN REACTIVE RATES FROM 2% TO 19% FOR (B)(6) 2023 AND (B)(6)2023. (B)(6) 2023 INITIAL REACTIVE SAMPLES WERE RECENTRIFUGED AND REPEAT REACTIVE IN DUPLICATE WITH CONFIRMED POSITIVE RESULTS THAT HAD SIMILAR S/CO VALUES AND % NEUTRALIZATION (NO SPECIFIC DATA WAS PROVIDED). (B)(6) 2023 AN OBSTETRIC GYNECOLOGY (OBGYN) PHYSICIAN QUESTIONED A CONFIRMED POSITIVE RESULT FOR A MOTHER OF A NEWBORN. THE PATIENTS THAT WERE REDRAWN WERE NEGATIVE FOR HBSAG AND THE VIRAL LOAD TESTING WAS PERFORMED ON 2 OF THE PATIENTS (ON THE REDRAWN SAMPLE) WERE NEGATIVE. THE SAMPLES THAT WERE REPEAT REACTIVE AND CONFIRMED REACTIVE WERE FROM OUTPATIENT LABORATORY SITES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952486 ↗
• InjuryOct 16, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT HBSAG QUALITATIVE CONFIRMATORY RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A FEMALE PATIENT WHO IS A MOTHER OF A NEWBORN. 25SEP2023 AN OBSTETRIC GYNECOLOGY (OBGYN) PHYSICIAN QUESTIONED A CONFIRMED POSITIVE RESULT FOR A MOTHER OF A NEWBORN. THE INITIAL REACTIVE RESULTS OF THE MOTHER WAS RECENTRIFUGED AND REPEAT REACTIVE IN DUPLICATE WITH A CONFIRMED POSITIVE RESULT THAT HAD SIMILAR S/CO VALUES AND % NEUTRALIZATION (NO SPECIFIC DATA WAS PROVIDED). BASED ON THE CONFIRMED RESULT, THE INFANT WAS GIVEN HEPATITIS B IMMUNE GLOBULIN TREATMENT. ON (B)(6) 2023 THE MOTHER WAS REDRAWN AND WAS NEGATIVE FOR HBSAG AND THE VIRAL LOAD TESTING PERFORMED WAS NEGATIVE. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17938451 ↗
• MalfunctionDec 12, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED REPEAT REACTIVE RESULTS FOR ARCHITECT HBSAG QUALITATIVE WITH NEGATIVE ARCHITECT HBSAG QUALITATIVE CONFIRMATORY RESULTS. THE FOLLOWING DATA WAS PROVIDED (UNIT OF MEASURE S/CO). SAMPLE ID (B)(6) ARCHITECT HBSAG QUALITATIVE: INITIAL RESULT = 173.51, REPEAT RESULT = 159.93 (BOTH REACTIVE) ARCHITECT HBSAG QUALITATIVE CONFIRMATORY = 45% (NOT CONFIRMED) ANOTHER LABORATORY PERFORMED TESTING AND CONFIRMED THE RESULTS. THE CUSTOMER BELIEVES THAT THE CONFIRMATORY RESULTS FROM THE OTHER LABORATORY ARE CORRECT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959996 ↗
• MalfunctionNov 12, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT HBSAG QUALITATIVE CONFIRMATORY RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: HBSAG INITIAL (NEAT) RESULT = 2559 S/CO, REPEATS = 2634 S/CO AND 2694.99S/C) HBSAG CONFIRMATORY RESULTS: 1:500 C2 = 99.76 (33.27%), 1:20000 C2 = 3.15 (37.3588%) A NEW SAMPLE WAS COLLECTED AND SENT TO CLEVELAND CLINIC FOR CONFIRMATION AND GENERATED POSITIVE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804801 ↗
• MalfunctionFeb 18, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A FALSE POSITIVE ARCHITECT HBSAG QUALITATIVE CONFIRMATORY RESULT. SAMPLE ID (B)(6) GENERATED REPEAT REACTIVE HBSAG RESULTS OF 16.82 S/CO WITH A SIMILAR RETEST AND CONFIRMED REACTIVE WITH THE HBSAG CONFIRMATORY ASSAY. A NEW SPECIMEN (S2676581) WAS COLLECTED TWO WEEKS LATER AND GENERATED REPEAT REACTIVE HBSAG RESULTS 16.27 S/CO WITH A SIMILAR RETEST RESULT AND NOT CONFIRMED WHEN TESTED WITH THE HBSAG CONFIRMATORY ASSAY. THE SAMPLE WAS ALSO SENT TO AN ALTERNATE LABE AND GENERATED A NON-REACTIVE RESULT. A THIRD SAMPLE (T4178124) GENERATED NON-REACTIVE RESULTS ON CONFIRMATION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9722645 ↗
• MalfunctionNov 22, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) ARCHITECT HBSAG RESULT ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 SID (B)(6) = (B)(6), (B)(6) BY HBSAG NEUTRALIZING CONFIRMATORY ASSAY (HBSAGC2 =(B)(6)). THE PHYSICIAN QUESTIONED THE RESULT, SAMPLE WAS SENT OUT FOR ADDITIONAL TESTING THAT PRODUCED A (B)(6) RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9361561 ↗
• MalfunctionNov 21, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ARCHITECT HBSAG RESULT ON ONE PATIENT. RESULTS PROVIDED: (B)(6) = 1.81 / 1.75 / 1.73 S/CO, CONFIRMED POSITIVE BY (B)(6) NEUTRALIZING CONFIRMATORY ASSAY ((B)(6) = 1.57 S/CO, (B)(6) %N = 100%). THE PHYSICIAN QUESTIONED THE RESULT, SAMPLE WAS SENT OUT FOR ADDITIONAL TESTING THAT PRODUCED A NEGATIVE RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9354161 ↗
• MalfunctionOct 28, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ARCHITECT HBSAG RESULT ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 SID (B)(6) = 1.38 / 1.29 / 1.43 S/CO. ARCHITECT HBSAG QUALITATIVE CONFIRMATORY TESTING = 102.364 (CONFIRMED REACTIVE). PATIENT WAS NONREACTIVE ON (B)(6) 2019 AND (B)(6) 2019 (NO DATA PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244816 ↗
• MalfunctionOct 3, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT HBSAG CONFIRMATORY TEST ON ONE (B)(6)YR.OLD FEMALE PATIENT. (B)(6) CONFIRMED REACTIVE WITH HBSAG NEUTRALIZATION ASSAY ON (B)(6) 2019 AT 100%; ROCHE HBV TEST AND ROCHE DNA (QUANTITATIVE ASSAY) WERE NOT DETECTED. PATIENT REDRAWN AND TESTED ON (B)(6) 2019, (B)(6) HBSAG QUALITATIVE = 0.32 S/CO (< 1.00 IS NONREACTIVE). OTHER RESULTS PROVIDED: HBCAB = 0.08 S/CO (NONREACTIVE); AUSAB = 8.56 / 8.46 / 8.96 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9151396 ↗
• MalfunctionJun 17, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED (B)(6) ARCHITECT HBSAG RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) ON (B)(6) 2019 (B)(6) / CONFIRMATORY TESTING = CONFIRMED / ON (B)(6) 2019 SAME PATIENT NEW SAMPLE (B)(6) / SAME PATIENT NEW SAMPLE ON (B)(6) 2019. (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704862 ↗
• MalfunctionMar 16, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) REPEATEDLY (B)(6) HBSAG QUALITATIVE RESULTS WHEN PROCESSING ON THE ARCHITECT I2000SR. ADDITIONAL RNA/DNA TESTING WAS (B)(6). THE INITIAL RESULT WAS (B)(6) AND RETEST RESULTS WERE (B)(6). A NEW SAMPLE WAS DRAWN AND YIELDED RESULTS OF (B)(6). ANOTHER RETEST OF THE ORIGINAL SAMPLE GENERATED RESULTS OF (B)(6). CONFIRMATORY AND NEUTRALIZATION TESTING YIELDED RESULTS OF (B)(6), RESPECTIVELY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8427041 ↗
• MalfunctionMar 11, 2019False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A (B)(6) RESULT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL (B)(6), REPEATS (B)(6); CONFIRMED (B)(6). THE SAMPLE WAS CONFIRMED (B)(6) AT ANOTHER LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8409140 ↗
• MalfunctionFeb 13, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED (B)(6) ARCHITECT HBSAG RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6); CONFIRMATORY TESTING (B)(6) = CONFIRMED (B)(6). THE CUSTOMER QUESTIONED THE RESULTS BECAUSE THE (B)(6) RESULT = (B)(6) INDICATING IMMUNITY TO (B)(6), SO THEY RETESTED THE SAMPLE = (B)(6)). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336437 ↗
• MalfunctionFeb 12, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) ARCHITECT HBSAG QUALITATIVE CONFIRMATORY RESULT FOR ONE BONE MARROW TRANSPLANT PATIENT. SAMPLE ID (B)(6) GENERATED A CONFIRMED (B)(6) RESULT OF (B)(6) WITH 75% NEUTRALIZATION. THE CUSTOMER FURTHER INDICATED THE SAMPLE GENERATED A (B)(6) ARCHITECT HBSAG QUALITATIVE RESULT (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8332613 ↗
• MalfunctionJan 4, 2019False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING ARCHITECT HBSAG CONFIRMATORY REAGENTS. THE FOLLOWING DATA WAS PROVIDED. CONFIRMATORY TEST WAS (B)(6) HOWEVER NO SPECIFIC VALUES WERE PROVIDED. TEST RESULTS FOR THE PATIENT USING ARCHITECT HBSAG QUALITATIVE REAGENTS WERE PROVIDED: SID (B)(6) TESTED (B)(6) 2018 INITIAL (B)(6), REPEAT IN DUPLICATE WAS (B)(6) HOWEVER ONLY ONE (B)(6) REPEAT RESULT WAS PROVIDED ((B)(6)) AND WAS FLAGGED AS EXP. RETESTING AFTER RECENTRIFUGING THE SPECIMEN WAS (B)(6), THE CUSTOMER DID NOT PROVIDE THE VALUE. A PREVIOUS SPECIMEN TESTED (B)(6) 2018 WAS (B)(6) (SID (B)(6)). A SUBSEQUENT SPECIMEN TESTED (B)(6) 2018 WAS ALSO (B)(6) ((B)(6)). THE CUSTOMER STATED THE PATIENT WAS (B)(6) THREE MONTHS BEFORE THE CURRENT TEST AND WAS (B)(6), HOWEVER NO SPECIFIC VALUE OR METHOD WAS PROVIDED. THE PATIENT WAS PREGNANT AND WAS ABOUT TO GIVE BIRTH WHEN THE INITIAL SPECIMEN WAS DRAWN. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8217679 ↗
• MalfunctionOct 15, 2018False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSELY (B)(6) RESULTS WHILE USING ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID 51403339 INITIAL 0.68 S/CO (B)(6), REPEAT 1.00 S/CO (B)(6), 2742.65 S/CO (B)(6) MULTIPLE HBSAG RESULTS WERE (B)(6) WHILE USING THE QUALITATIVE ASSAY (2876.73 S/CO, 2783.34 S/CO, 2884.78 S/CO). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7967774 ↗
• MalfunctionAug 16, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED MULTIPLE (B)(6) RESULTS WHILE USING ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) (TESTED (B)(6) 2018) INITIAL (B)(6) ((B)(6)), REPEAT (B)(6) ((B)(6)). CONFIRMATORY TESTING WAS (B)(6). (B)(6) METHOD WAS (B)(6). SID (B)(6) (TESTED (B)(6) 2018) INITIAL (B)(6) ((B)(6)), REPEAT (B)(6) ((B)(6)). CONFIRMATORY TESTING WAS (B)(6). THE CUSTOMER STATED THE SAME SPECIMEN WAS REPEATED AN HOUR AND A HALF LATER AND (B)(6) RESULTS WERE OBSERVED FOR BOTH METHODS, HOWEVER THE SPECIFIC VALUES WERE NOT PROVIDED. (B)(6) METHOD WAS (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7791591 ↗
• MalfunctionMar 8, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) RESULTS, WHILE USING THE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ASSAYS. SAMPLE ID (B)(6) GENERATED A REPEAT (B)(6) RESULT OF (B)(6) AND CONFIRMATORY TESTING CONFIRMED AT 93%. THE ORIGINAL AND A SECOND SAMPLE FROM THE PATIENT WERE RETESTED IN DUPLICATE GENERATING NEGATIVE RESULTS RANGING FROM (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7325334 ↗
• MalfunctionSep 28, 2017False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) ARCHITECT HBSAG RESULT FOR A (B)(6) MALE DIALYSIS PATIENT. THE CUSTOMER FURTHER INDICATED THE ARCHITECT HBSAG CONFIRMATORY RESULT WAS 98%. THE CUSTOMER FURTHER INDICATED A MONTH LATER THE PATIENT GENERATED (B)(6) RESULTS. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901131 ↗
• MalfunctionJul 12, 2017False Positive Result; False Positive Result

  THE ACCOUNT GENERATED FALSE CONFIRMED (B)(6) ARCHITECT HBSAG QUALITATIVE ON A PATIENT WHO REPEATED (B)(6) WITH A NEW SAMPLE AND VIRAL LOAD (B)(6). DATA PROVIDED WAS ARCHITECT HBSAG QUALITATIVE (B)(6) AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ((B)(6) NEURALIZATION). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6706783 ↗
• MalfunctionMay 16, 2017False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT A WEAK (B)(6) ARCHITECT (B)(6) RESULT WAS GENERATED FOR A PATIENT ON (B)(6) 2017. THE SAMPLE RETESTED (B)(6) AND CONFIRMED (B)(6) USING THE ARCHITECT (B)(6) QUALITATIVE CONFIRMATORY ASSAY. THE SAME PATIENT WAS REDRAWN THE FOLLOWING DAY AND THE RESULT WAS (B)(6). THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE RESULT WAS (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6570019 ↗
• MalfunctionMar 20, 2017Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED (B)(6) CONFIRMATORY (B)(6) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) ON (B)(6) 2017 INITIAL = (B)(6) / RE-CENTRIFUGED AND RETESTED = (B)(6). (B)(6) CONFIRMATORY TESTING = (B)(6) / -3% NEUT = NOT CONFIRMED. THE CUSTOMER REPEATED THE CONFIRMATORY TESTING = (B)(6) / 79% NEUT = CONFIRMED (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6417392 ↗
• MalfunctionFeb 6, 2017High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED A (B)(6) RESULT ON A LABOR AND DELIVERY PATIENT. THE RESULTS FROM (B)(6) 2017 =1.43S/CO / SAMPLE REPEATED = 1.36S/CO (>/=1.00S/CO = (B)(6)) / CONFIRMATORY TESTING PERFORMED = C2 1.30 / NEUTRALIZATION = 102.94% (C2 >/=0.70 AND % NEUT >/=50% = CONFIRMED (B)(6)). PHYSICIAN QUESTIONED THE RESULTS AND REQUESTED A NEW SAMPLE, DRAWN (B)(6) 2017 = 0.75S/CO (<1.00S/CO = (B)(6)). THE CUSTOMER RETESTED THE (B)(6) 2017 SAMPLE AFTER RE-CENTRIFUGING AND GENERATED 1.36 / 1.41 / REPEATED CONFIRMATORY = C2 1.30 / 100.619% NEUT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304398 ↗