Alinity 06P0260Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00380740136819), received between Sep 2, 2021 and Mar 5, 2026 — classified as 100 injuries, 17 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (117 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 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY RESULTS GENERATED FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE >/= 1.0 S/CO IS REACTIVE): UNIT OF MEASURE = S/CO. SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 3.6, REPEAT RESULTS ON (B)(6) = 2.4, 2.31; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 3, REPEAT RESULTS ON (B)(6) = 2.56, 2.07; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 4.49, REPEAT RESULTS ON (B)(6) = 4.36, 4.72; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 2.84, REPEAT RESULTS ON (B)(6) = 2.56, 2.81; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 2.09, REPEAT RESULTS ON (B)(6) = 1.39, 1.35; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 2.99, REPEAT RESULTS ON (B)(6) = 2.71, 2.45; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 1.53, REPEAT RESULTS ON (B)(6) = 1.36, 1.27; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 1.37, REPEAT RESULTS ON (B)(6) = 1.09, 1.16; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 6.15, REPEAT RESULTS ON (B)(6) = 2.95, 2.93; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 20.97, REPEAT RESULTS ON (B)(6) = 12, 12.35; SAMPLE ID (B)(6) INITIAL RESULT ON (B)(6) = 10.08, REPEAT RESULTS ON (B)(6) = 6.13, 6.06;

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518511 ↗
• MalfunctionFeb 3, 2026False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY. THE CUSTOMER REPORTED THAT THE FOLLOWING SAMPLES WERE REPEAT REACTIVE FOR ALINITY S HBSAG AND CONFIRMED WITH ALINITY S HBSAG CONFIRMATORY THE CUSTOMER REPORTED THAT FURTHER SUPPLEMENTAL TESTING WAS PERFORMED. NAT TESTING GENERATED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT TESTING OCCURRED BETWEEN (B)(6) 2025 AND PROVIDED THE FOLLOWING DATA: REFERENCE RANGE: = 1.0 S/CO IS REACTIVE SAMPLE ID (B)(6) HBSAG RESULTS WERE 3.88, 2.95 & 2.45. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULTS WERE 152.90, 148.10, & 147.71. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULT WAS 17.37. SAMPLE CONFIRMED POSITIVE WITH ALINITY S HBSAG CONFIRMATORY AND NAT TESTING GENERATED A NEGATIVE RESULT. SAMPLE ID (B)(6) HBSAG RESULT WAS 10.08, 6.13 & 6.06. RESULTS GENERATED FROM ALINITY S ANALYZER SN: (B)(6). SAMPLE CONFIRMED P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246864 ↗
• MalfunctionNov 3, 2025False Positive Result; False Positive Result

  AN ARTICLE BY SARA O. DIONNE, HILLARY C. S. R. AKANA, MICHAEL REAL, KIMBERLY A. ELLIOTT, BRENDEN R. O¿NEALE ¿INCREASED SEROLOGIC REACTIVITY WITH AUTOMATED CMIA TESTING AND ITS IMPLICATIONS FOR DECEASED DONOR ELIGIBILITY DETERMINATION IN THE UNITED STATES¿, CELL TISSUE BANK (2025) 26:40 MENTIONS REPEAT REACTIVE RESULTS FOR SAMPLES WITH ALINITY S HIV AG/AB COMBO, ALINITY S HTLV I/II, ALINITY S ANTI-HCV, ALINITY S HBSAG, AND ALINITY S ANTI-HBC. IT ALSO STATES THAT SOME SAMPLES WERE DISCREPANT TO NAT. THESE RESULTS COULD LEAD TO REJECTION OF DONATED TISSUE SAMPLES. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449354 ↗
• MalfunctionSep 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS ON 4 CADAVERIC PATIENTS. SAMPLE 3 WAS ALSO RETESTED USING A PRE-MORTEM SAMPLE WITH REACTIVE RESULTS ON THE ALINITY, NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS ON THE PRE-MORTEM SAMPLE. NAT AND BIORAD EIA WERE NEGATIVE FOR ALL SAMPLES. FURTHER TESTING ON THE ALINITY HAD MIXED REACTIVE AND NONREACTIVE RESULTS. TISSUE SAMPLES WERE DISCARDED FOR ALL 4. THE FOLLOWING DATA WAS PROVIDED (REFERENCE = 1.0 S/CO IS REACTIVE): SAMPLE 1 TESTING: ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 2.32, 2.03, 1.90, 2.10, 2.40. ON (B)(6) ,2024 SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.23, REPEAT RESULT = 0.82 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6), (EDTA SAME PATIENT AS SID(B)(6): PANTHER RESULT = NONREACTIVE. SAMPLE 2 TESTING: ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.90, 1.89, 2.17 ON (B)(6)2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.59, REPEAT RESULT = 0.89 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128647 ↗
• MalfunctionSep 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS ON 4 CADAVERIC PATIENTS. SAMPLE 3 WAS ALSO RETESTED USING A PRE-MORTEM SAMPLE WITH REACTIVE RESULTS ON THE ALINITY, NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS ON THE PRE-MORTEM SAMPLE. NAT AND BIORAD EIA WERE NEGATIVE FOR ALL SAMPLES. FURTHER TESTING ON THE ALINITY HAD MIXED REACTIVE AND NONREACTIVE RESULTS. TISSUE SAMPLES WERE DISCARDED FOR ALL 4. THE FOLLOWING DATA WAS PROVIDED (REFERENCE = 1.0 S/CO IS REACTIVE): SAMPLE 1 TESTING: ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 2.32, 2.03, 1.90, 2.10, 2.40. ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.23, REPEAT. RESULT = 0.82 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6), (EDTA SAME PATIENT AS (B)(6): PANTHER RESULT = NONREACTIVE. SAMPLE 2 TESTING: ON (B)(6) 2024, SID (B)(6), (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.90, 1.89, 2.17. ON (B)(6) 2024, SID (B)(6) (SERUM) ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6) = 1.59, REPEAT. RESULT = 0.89 (PROCESSED ON (B)(6). BIORAD EIA RESULT = NONREACTIVE. SID (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128405 ↗
• InjurySep 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS WERE GENERATED FOR A POTENTIAL PRE-MORTEM DONOR OF ADVANCED AGE. THE CUSTOMER STATED THAT LIVER TRANSPLANTATION WAS A POSSIBILITY AND NO SPECIFIC RECIPIENT HAD BEEN IDENTIFIED, HOWEVER FURTHER EVALUATION AND CONSIDERATION FOR A POTENTIAL RECIPIENT WAS NO LONGER PURSUED AFTER RECEIPT OF THE REACTIVE RESULTS, AS THERE WERE NO SUITABLE RECIPIENTS TO RECEIVE THE LIVER FROM A DONOR OF ADVANCED AGE WITH SUSPICION/CONCERN OF HBSAG AND THEREFORE ORGAN RECOVERY WAS ABORTED. THE CUSTOMER FURTHER STATED THAT THEY WOULD HAVE CONTINUED WITH EVALUATION AND POTENTIAL FOR THIS CASE IF THE RESULTS HAD BEEN NONREACTIVE. NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS. NAT TESTING, BIORAD EIA, AND FURTHER REPEAT TESTING ON THE ALINITY S WERE NONREACTIVE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE = 1.0 S/CO IS REACTIVE): (B)(6) 2024 SID (B)(6): ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.38, 1.31, 1.39. SID (B)(6): PANTHER RESULT = NONREACTIVE. (B)(6) 2024 SID (B)(6): ALINITY S HBSAG RESULT (PROCESSED ON (B)(6)) = 1.74, REPEAT RESULT = 0.59 NONREACTIVE (PROCESSED ON (B)(6)). (B)(6) 2024 SID (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127772 ↗
• InjurySep 3, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG RESULTS WERE GENERATED FOR A POTENTIAL PRE-MORTEM DONOR OF ADVANCED AGE. THE CUSTOMER STATED THAT LIVER TRANSPLANTATION WAS A POSSIBILITY AND NO SPECIFIC RECIPIENT HAD BEEN IDENTIFIED, HOWEVER FURTHER EVALUATION AND CONSIDERATION FOR A POTENTIAL RECIPIENT WAS NO LONGER PURSUED AFTER RECEIPT OF THE REACTIVE RESULTS, AS THERE WERE NO SUITABLE RECIPIENTS TO RECEIVE THE LIVER FROM A DONOR OF ADVANCED AGE WITH SUSPICION/CONCERN OF HBSAG AND THEREFORE ORGAN RECOVERY WAS ABORTED. THE CUSTOMER FURTHER STATED THAT THEY WOULD HAVE CONTINUED WITH EVALUATION AND POTENTIAL FOR THIS CASE IF THE RESULTS HAD BEEN NONREACTIVE. NO NEUTRALIZING CONFIRMATORY TESTING PERFORMED FOR THE REACTIVE ALINITY S HBSAG RESULTS. NAT TESTING, BIORAD EIA, AND FURTHER REPEAT TESTING ON THE ALINITY S WERE NONREACTIVE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE = 1.0 S/CO IS REACTIVE): (B)(6) 2024 SID (B)(6): ALINITY S HBSAG RESULTS (PROCESSED ON SN (B)(6)) = 1.38, 1.31, 1.39 SID (B)(6): PANTHER RESULT = NONREACTIVE (B)(6) 2024 SID (B)(6): ALINITY S HBSAG RESULT (PROCESSED ON (B)(6)) = 1.74, REPEAT RESULT = 0.59 NONREACTIVE (PROCESSED ON (B)(6)). (B)(6) 2024 SID (B)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127682 ↗
• MalfunctionJun 4, 2024False Positive Result; False Positive Result

  THE SAN ANTONIO EYE BANK (SAEB) REPORTED THAT ITS STATISTICS FOR 2023 SHOWED AN INCREASE OF REACTIVE HBSAG RESULTS FOR CADAVERIC (NON-HEART BEATING) SAMPLES THAT APPEARS TO COINCIDE WITH THE IMPLEMENTATION/VALIDATION OF THE ALINITY S SYSTEM IN LATE 2021 AT QUALTEX LABORATORIES (SAN ANTONIO EYE BANK UTILIZES QUALTEX LABORATORIES FOR TESTING OF THEIR HBSAG CADAVERIC SAMPLES). IN 2021 THERE WERE 3.0% HBSAG REACTIVE SAMPLES (73 CORNEAS) AND IN 2023 THERE WERE 7.3% HBSAG REACTIVE SAMPLES (153 CORNEAS). FOR 2023, 0.002% OF THESE WERE BOTH HBSAG AND HBV NAT REACTIVE (4 CORNEAS) AND 0.0019% (6 CORNEAS) TOTAL WERE HBV NAT REACTIVE. NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462861 ↗
• MalfunctionMay 20, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HBSAG RESULTS FOR THREE CADAVERIC SAMPLES. TISSUES FOR ALL THREE WERE DISCARDED. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = S/CO): E00000145 HBSAG INITIAL RESULT = 7.17 REPEAT RESULTS = 7.47 AND 5.03 SAMPLE IS SLIGHTLY HEMOLYZED WITH VISIBLE PARTICULATES PRESENT GRIFOLS PROCLEIX NAT WAS NONREACTIVE. E00000175 HBSAG INITIAL RESULT = 1.66 REPEAT RESULTS = 1.39 AND 1.36 SAMPLE IS SLIGHTLY HEMOLYZED WITH LARGE PARTICULATE PRESENT GRIFOLS PROCLEIX NAT WAS NONREACTIVE. E00000182 HBSAG INITIAL RESULT = 2.29 REPEAT RESULTS = 2.01 AND 2.09 SAMPLE IS SLIGHTLY HEMOLYZED GRIFOLS PROCLEIX NAT WAS NONREACTIVE. ADDITIONAL DATA PROVIDED 12JUNE2024: THE THREE SAMPLES WERE REPEATED AFTER BEING SPUN AT 5000 RPM FOR 15 MINUTES AND VISIBLE PARTICULATE MATTER REMOVED. THE SAMPLES WERE REPEATED ON SERIAL NUMBER (B)(6). E00000145 WAS ALIQUOTED INTO 2 TUBES BY THE TECH, EACH TUBE WAS TESTED INDIVIDUALLY TO CONFIRM RESULTS MATCHED. THE HBSAG TUBES WERE RUN ON BIO-RAD'S HBSAG PLATE KIT. ALL TUBES WERE NONREACTIVE SID ¿ ASSAY ¿ PRESPUN VISIBLE PARTICULATES ¿ SPUN VISIBLE PARTICULATES ¿ ALINITY S RERUN RESULT. E00000145 HBSAG ¿ FEW CHUNKS ¿ ACCEPTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354375 ↗
• MalfunctionMay 14, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE HBSAG THE ALINITY S PROCESSING MODULE FOR 6 CADAVERIC SAMPLES THAT ARE RED IN APPEARANCE. THE RESULTS DID NOT MATCH THE PATIENT¿S HISTORY. THERE WAS NO CONFIRMATORY TESTING PERFORMED. THE TISSUES WERE DISCARDED. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2024 HBSAG (B)(6) RESULTS = 8.22 7.78/8.00 NAT TESTING NOT PERFORMED TISSUE WAS DISCARDED. TESTED ON (B)(6) 2024 HBSAG (B)(6) RESULTS = 5.98 6.10/6.18 NAT TESTING NOT PERFORMED TISSUE WAS DISCARDED. TESTED ON (B)(6) 2024 HBSAG (B)(6) (FROM SAME SAMPLE AS (B)(6)) RESULTS = 4.82 4.26/4.56 NAT TESTING NOT PERFORMED TISSUE WAS DISCARDED. TESTED ON (B)(6) 2024 HBSAG (B)(6) RESULTS = 2.35 2.07/2.23 NAT TESTING NOT PERFORMED TISSUE WAS DISCARDED. TESTED ON (B)(6) 2024 HBSAG (B)(6) RESULTS = 1.73 1.46/1.59 NAT TESTING NOT PERFORMED TISSUE WAS DISCARDED. TESTED ON (B)(6) 2024 HBSAG (B)(6) RESULTS= 4.63 4.40/4.52 NAT TESTING NOT PERFORMED TISSUE WAS DISCARDED. TESTED ON (B)(6) 2024 HBSAG (B)(6)(S) RESULTS = 1.2 1.62/1.68 NAT TESTING NOT PERFORMED TISSUE WAS DISCARDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312387 ↗
• MalfunctionApr 11, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HBSAG AND HTLV I/II RESULTS FOR (B)(4) DONORS. THE CUSTOMER STATED DONORS WERE TESTED WITH ANOTHER METHOD AND NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER STATES THEY HAVE HAD 10 REPEAT REACTIVE HBSAG(SINCE (B)(6) 2024) AND 2 REPEAT REACTIVE HTLV I/II(IN (B)(6) 2024) THAT WERE SENT FOR CONFIRMATORY NAT TESTING THAT WAS NEGATIVE. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC RESULT INFORMATION. ADDITIONAL INFORMATION FROM 10APR2024: SINCE THE BEGINNING OF(B)(6), 5 MORE REPEAT REACTIVE ALINITY S HBSAG AND 2 MORE REPEAT REACTIVE HTLV. THERE WAS NO FURTHER RESULT INFORMATION PROVIDED OR NONREACTIVE RESULT PROVIDED. ALL (B)(4) TOTAL SAMPLES WERE CADAVERIC AND SLIGHTLY HEMOLYZED. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093622 ↗
• MalfunctionApr 11, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HBSAG AND HTLV I/II RESULTS FOR 12 DONORS. THE CUSTOMER STATED DONORS WERE TESTED WITH ANOTHER METHOD AND NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER STATES THEY HAVE HAD 10 REPEAT REACTIVE HBSAG(SINCE JAN2024) AND 2 REPEAT REACTIVE HTLV I/II(IN MARCH2024) THAT WERE SENT FOR CONFIRMATORY NAT TESTING THAT WAS NEGATIVE. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC RESULT INFORMATION. ADDITIONAL INFORMATION FROM 10APR2024: SINCE THE BEGINNING OF APRIL, 5 MORE REPEAT REACTIVE ALINITY S HBSAG AND 2 MORE REPEAT REACTIVE HTLV. THERE WAS NO FURTHER RESULT INFORMATION PROVIDED OR NONREACTIVE RESULT PROVIDED. ALL 19 TOTAL SAMPLES WERE CADAVERIC AND SLIGHTLY HEMOLYZED. ADDITIONAL INFORMATION FROM 12APR2024: ALL HBSAG REACTIVE SAMPLES WERE REJECTED FOR TISSUE DONATIONS. FOR HTLV REACTIVE DISPOSITION STATUS NOT PROVIDED. HTLV IMMUNOBLOT RESULTS FOR THE TWO ADDITIONAL SAMPLES FROM APRIL WERE NEGATIVE. ADDITIONAL INFORMATION FROM 15APR2024: THE SAMPLE PROVIDED BELOW ARE SPECIFIC RESULTS/INFORMATION FROM THE TESTING IN APRIL. 3 NEW HBSAG POSITIVE SAMPLES ARE INCLUDED THAT WERE RAN ON (B)(6) 2024, (B)(6) 2024, AND (B)(6) 2024. THE OTHER 5 HBSAG AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093582 ↗
• MalfunctionJan 30, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HBSAG RESULTS FOR MULTIPLE CADAVERIC SAMPLES WHICH WERE CONFIRMED AS NEGATIVE WITH NAT TESTING. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): (B)(6). 2024 SID (B)(6). INITIAL RESULT = 1.98 S/CO, REPEATS = 2.12 S/CO AND 1.97 S/CO, NAT = NEGATIVE (B)(6). 2024 SID (B)(6). INITIAL RESULT = 1.13 S/CO, REPEATS = 1.12 S/CO AND 1.18 S/CO, NAT = NEGATIVE (B)(6). 2024 SID (B)(6). INITIAL RESULT = 1.34 S/CO, REPEATS = 1.57 S/CO AND 1.46 S/CO, NAT = NEGATIVE (B)(6). 2024 SID (B)(6). INITIAL RESULT = 6.32 S/CO, REPEATS = 6.61 S/CO AND 6.82 S/CO, NAT = NEGATIVE (B)(6). 2024 SID (B)(6). INITIAL RESULT = 1.16 S/CO, REPEATS = 1.15 S/CO AND 1.14 S/CO, NAT = NEGATIVE (B)(6). 2024 SID (B)(6). INITIAL RESULT = 1.71 S/CO, REPEATS = 1.22 S/CO AND 1.17 S/CO, NAT = NEGATIVE (B)(6). 2024 SID (B)(6). INITIAL RESULT = 3.74 S/CO, REPEATS = 3.15 S/CO AND 3.22 S/CO, NAT = NEGATIVE (B)(6). 2024 SID (B)(6). INITIAL RESULT = 1.34 S/CO, REPEATS = 1.09 S/CO AND 1.29 S/CO, NAT = NEGATIVE (B)(6). 2024 SID (B)(6). INITIAL RESULT = 1.51 S/CO, REPEATS = 1.14 S/CO AND 1.18 S/CO, NAT = NEGATIVE (B)(6). 2024 SID (B)(6). INITIAL RESU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607850 ↗
• MalfunctionNov 15, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG ASSAY ON CADAVERIC SAMPLE AND PROVIDED THE FOLLOWING INFORMATION: REFERENCE = 1.0 S/CO IS REACTIVE. ON (B)(6) 2023, SAMPLE ID (B)(6) INITIAL RESULT WAS 16.99 (REACTIVE) AND REPEAT RESULTS WERE 16.99 (REACTIVE) & 15.64 (REACTIVE). NAT RESULT WAS NEGATIVE. TISSUE STATUS: RETAINED, MOTHER TESTED NEGATIVE ON (B)(6) 2023. PATIENT INFORMATION: 3 DAY OLD MALE WHO WAS FOUND UNRESPONSIVE AT HOME. INFORMATION REGARDING MEDICATIONS: 4 DOSES OF EPINEPHRINE. HEPATITIS B VACCINATION OCCURRED ON (B)(6) 2023. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143029 ↗
• InjuryNov 15, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG ASSAY ON CADAVERIC SAMPLES AND PROVIDED THE FOLLOWING INFORMATION: REFERENCE = 1.0 S/CO IS REACTIVE ON (B)(6) 2023, SAMPLE ID (B)(6) INITIAL RESULT WAS 1.57 (REACTIVE) AND REPEAT RESULTS WERE 1.46 (REACTIVE) & 1.26 (REACTIVE). NAT RESULT WAS NEGATIVE. TISSUE STATUS: DISCARDED PATIENT INFORMATION: 3-MONTH-OLD MALE WHO WAS FOUND UNRESPONSIVE AT HOME. INFORMATION REGARDING MEDICATIONS: 4 DOSES OF EPINEPHRINE. HEPATITIS B VACCINATION STATUS WAS UNKNOWN, HOWEVER THE PATIENT HAD 2 MONTHS OF UNSPECIFIED VACCINES. DONOR TISSUE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142999 ↗
• InjuryNov 15, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HBSAG ASSAY ON CADAVERIC SAMPLES AND PROVIDED THE FOLLOWING INFORMATION: REFERENCE = 1.0 S/CO IS REACTIVE. ON (B)(6) 2023, SAMPLE ID (B)(6) INITIAL RESULT WAS 5.27 (REACTIVE) AND REPEAT RESULTS WERE 4.63 (REACTIVE) & 4.84 (REACTIVE). NAT RESULT WAS NEGATIVE. TISSUE STATUS: DISCARDED PATIENT INFORMATION: 1 MONTH OLD MALE WHO WAS FOUND UNRESPONSIVE AT HOME AND NO INFORMATION REGARDING MEDICATIONS WERE PROVIDED. HEPATITIS B VACCINATION STATUS WAS UNKNOWN. DONOR TISSUE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142996 ↗
• InjuryOct 24, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HBSAG RESULTS FOR A CADAVERIC TISSUE A DONOR SAMPLES THAT WAS CONFIRMATORY TESTING AND NAT NEGATIVE. THE RESULTS PROVIDED WERE: SID (B)(6) 58YRS OLD MALE: HBSAG= REPEAT REACTIVE (NO ACTUAL RESULTS PROVIDED) /NAT=NEGATIVE /CONFIRMATORY TESTING=NEGATIVE. ALL OTHER HEPATITIS B TESTING NONREACTIVE (NEGATIVE) FOR THIS DONOR. THE TISSUE WAS DISCARDED FOR IMPACTED SIDS. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995533 ↗
• InjuryOct 24, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HBSAG RESULTS FOR A CADAVERIC TISSUE A DONOR SAMPLES THAT WAS CONFIRMATORY TESTING AND NAT NEGATIVE. THE RESULTS PROVIDED WERE: SID (B)(6) 45YRS OLD MALE: HBSAG=REPEAT REACTIVE (NO ACTUAL RESULTS PROVIDED) /NAT=NEGATIVE /CONFIRMATORY TESTING=NEGATIVE ALL OTHER HEPATITIS B TESTING NONREACTIVE (NEGATIVE) FOR THIS DONOR. THE TISSUE WAS DISCARDED FOR IMPACTED SIDS. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995325 ↗
• MalfunctionOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HBSAG RESULTS ON MULTIPLE DONORS. THE FOLLOWING RESULTS WERE PROVIDED: DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.45 / 1.43 / 1.63 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.88 / 1.46 / 1.33 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.47 / 1.07 / 1.20 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.11 / 1.05 / 1.10 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.49 / 1.58 / 1.61 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.08 / 0.99 / 1.04 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.58 / 1.66 / 1.66 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.81 / 2.11 / 2.34 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.53 / 1.18 / 1.23 S/CO; NAT RESULT: NEGATIVE. DATE: (B)(6) 2023; ASSAY: HBSAG; SID: (B)(6); ALINITY RESULTS: = 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949976 ↗
• InjuryOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HBSAG RESULTS ON FOUR DONORS. THE FOLLOWING RESULTS WERE PROVIDED: DATE SID ALINITY RESULTS NAT RESULT TISSUE DISPOSITION ON (B)(6) 2023, (B)(6) = 1.17 / 1.21 / 1.35 S/CO, NEGATIVE, DISCARDED. DONOR TISSUE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948456 ↗
• InjuryOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HBSAG RESULTS ON FOUR DONORS. THE FOLLOWING RESULTS WERE PROVIDED: DATE SID ALINITY RESULTS NAT RESULT TISSUE DISPOSITION. (B)(6) = 1.28 / 1.20 / 1.25 S/CO NEGATIVE DISCARDED. DONOR TISSUE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948420 ↗
• InjuryOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HBSAG RESULTS ON FOUR DONORS. THE FOLLOWING RESULTS WERE PROVIDED: DATE SID ALINITY RESULTS NAT RESULT TISSUE DISPOSITION (B)(6) 2023, (B)(6), = 1.09 / 1.07 / 1.01 S/CO, NEGATIVE, DISCARDED. DONOR TISSUE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948373 ↗
• InjuryOct 17, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ALINITY S HBSAG RESULT ON A TISSUE DONOR. THE FOLLOWING RESULTS WERE PROVIDED: DATE SID ALINITY RESULTS NAT RESULT TISSUE DISPOSITION (B)(6) 2023, (B)(6), = 1.04 / 1.24 / 1.19 S/CO, NEGATIVE, DISCARDED. DONOR TISSUE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948337 ↗
• MalfunctionJul 28, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG AND ALINITY S HBSAG CONFIRMATORY RESULTS GENERATED FOR A DONOR SAMPLE. THE FOLLOWING DATA WAS PROVIDED: 29JUN2023 SAMPLE ID (B)(6) INITIAL RESULT = 1.80 S/CO, REPEATED TWICE AND RESULTS = 1.69 S/CO AND 1.68 S/CO, REPEATED WITH AN ALTERNATE METHOD AND RESULT = NON-REACTIVE. 30JUN2023 ALINITY S HBSAG CONFIRMATORY TEST WAS PERFORMED ON ANALYZER WITH SERIAL NUMBER AS1225, AND GENERATED POSITIVE RESULT: %N = 87.64%. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413973 ↗
• InjuryJun 28, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HBSAG RESULTS FOR A CADAVERIC SAMPLE. THE FOLLOWING DATA WAS PROVIDED (>/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6), 48-YEAR-OLD MALE, INITIAL RESULT, ON (B)(6) 2023, WAS 1.68, REPEATS WERE 1.36 AND 1.46 S/CO. THE SAMPLE WAS NEGATIVE WHEN TESTED WITH NAT. THE ASSOCIATED TISSUES FROM THIS DONOR WERE DISCARDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221745 ↗